Datasets:

emericklaf
/

multimodal-rag-pharma-data

query_id int64	query large_string	language large_string	query_types list	query_format large_string	content_type list	raw_answers list	query_generator large_string	query_generation_pipeline large_string	source_type large_string	query_type_for_generation large_string	answer large_string	has_visual_qrel bool
1,038	C'è stato un aumento dei decessi per overdose correlati agli oppioidi negli Stati Uniti dal 2000 al 2015?	italian	[ "boolean" ]	question	[ "Chart", "Infographic", "Text" ]	[ "Yes, from 2000 to 2015, there was an increase in opioid-related overdose deaths in the United States. In 2015, the deaths recorded were 33,091.", "Yes, there was a significant rise in opioid-related overdose fatalities in the United States from 2000 to 2015 as shown by the increasing line graph." ]	sdg	gretel	summary	boolean	Sì, c'è stato un aumento delle morti per sovradosaggio legate agli oppioidi negli Stati Uniti dal 2000 al 2015. Il numero di morti coinvolgenti qualsiasi oppioide è aumentato dal 2000 al 2015, raggiungendo 33.091 nel 2015.	true
855	¿Cuáles fueron los principales pasos regulatorios emprendidos por el CDER de la FDA durante la pandemia para abordar los nuevos tratamientos a medida que surgían?	spanish	[ "enumerative", "open-ended" ]	question	[ "Image", "Text" ]	[ "1. Emergency program for potential coronavirus therapies\n2. Leverage cross-agency scientific resources and expertise\n3. Facilitate fast, early, and frequent discussions between the FDA and drug sponsors\n4. Providing timely feedback to the industry on clinical trial development\n5. Integrate data to help assess ...	sdg	gretel	summary	enumerative	Durante la pandemia, CDER llevó a cabo varios pasos regulatorios importantes para abordar nuevos tratamientos. Estos incluyeron el establecimiento del Programa de Aceleración del Tratamiento del Coronavirus (CTAP), un programa de emergencia creado en abril de 2020 para agilizar el desarrollo y la revisión de posibles t...	true
144	Contrast the submission criteria for a complete ts.xpt file and a minimal ts.xpt file in FDA electronic submissions for nonclinical study data.	english	[ "compare-contrast", "extractive" ]	instruction	[ "Infographic", "Table", "Text" ]	[ "The submission criteria for a complete (full) ts.xpt file in FDA electronic submissions for nonclinical study data is that it should accompany SEND datasets, and it must follow the CDISC standards. Meanwhile, the criteria say that a minimal (simplified) ts.xpt file should be sent when a full SEND dataset is not re...	sdg	gretel	summary	compare-contrast	A full ts.xpt file accompanies SEND datasets and follows the published CDISC Standard. A simplified ts.xpt file is used when SEND datasets are not required for submissions in Modules 4.2.3.1, 4.2.3.2, or 4.2.3.4, and when using an STF file tag such as pre-clinical-study-report, legacy-clinical-study-report, or study-re...	true
570	L'emballage unitaire par utilisation améliore-t-il la sécurité des analgésiques opioïdes ?	french	[ "boolean" ]	question	[ "Infographic", "Table", "Text" ]	[ "Yes, 'unit-of-use packaging' does improve opioid analgesic safety.", "Yes, the \"unit-of-use packaging\" is used as a strategy to improve opioid analgesic safety." ]	human	null	image	boolean	Oui, 'unit-of-use packaging' est utilisé comme stratégie pour améliorer la sécurité des analgésiques opioïdes.	true
1,384	Vergleichen Sie die Auswirkungen der FDAAA 2007-Anforderungen und des 21st Century Cures Act auf die Praktiken der Nachmarktsicherheitsüberwachung von Arzneimitteln hinsichtlich regulatorischer Maßnahmen und Überwachungsflexibilität.	german	[ "compare-contrast" ]	instruction	[ "Image", "Text" ]	[ "FDAAA 2007 established a requirement for preparing a summary analysis of drug reaction reports after 18 months of approval or after 10,000 patients had used it to identify new risks. However, an impact analysis found that these reviews had little value. Therefore, the 21st Century Cures Act removed the mandatory ...	sdg	gretel	summary	compare-contrast	FDAAA 2007 etablierte eine verpflichtende Anforderung für eine 18-Monats- oder 10.000-Patienten-Sicherheitsüberprüfung nach der Zulassung von Arzneimitteln, die eine Zusammenfassungsanalyse von Berichten über unerwünschte Arzneimittelwirkungen zur Identifizierung neuer oder ungewöhnlicher Risiken beinhaltete. Eine Ausw...	true
168	conditions leading to microbial contamination in pharmaceutical compounding settings	english	[ "open-ended" ]	keyword	[ "Image", "Text" ]	[ "Conditions leading to microbial contamination in pharmaceutical compounding settings:\n1. Gowned employee working in the cleanroom, exposing legs\n2. Filth under the hood\n3. Poor personnel practices\n4. Average normal human sheds about 37 million CFU/hour\n5. Dirty equipment located in the cleanroom\n6. Stains f...	sdg	custom_pipeline	summary	open-ended	Conditions leading to microbial contamination in pharmaceutical compounding settings include: exposed skin of an employee, filth such as medical supply waste and dust build-up in the pre-filter, dirty or stained equipment, visible microbial contamination on ceiling tiles, poor personnel practices like leaning into ISO-...	true
158	List the targeted initiatives launched by CDER to support rare disease innovation and their specific objectives.	english	[ "enumerative", "extractive" ]	instruction	[ "Chart", "Image", "Text" ]	[ "The targeted initiatives launched by CDER to support rare disease innovation and their specific objectives:\n- Coordinate the development of CDER Policies, Procedures, and Training, and assist in the development of good science\n- 58% new drug approvals and 31 approved NMEs in 2020\n- 94% novel orphan approved, an...	sdg	custom_pipeline	summary	enumerative	The targeted initiatives launched by CDER to support rare disease innovation include the Orphan Drug Technology Modernization effort, CDER's Rare Disease Development Council, and the Rare Disease Cure Accelerator. Their specific objectives are to coordinate the development of CDER policies, procedures, and training, as...	true
423	tendances de la crise des opioïdes opioïdes synthétiques contre opioïdes sur ordonnance 2000 à 2022	french	[ "compare-contrast", "open-ended" ]	keyword	[ "Chart", "Infographic", "Text" ]	[ "In the U.S., opioid overdose deaths have increased fourfold since 2002. This big jump is mainly because of synthetic opioids like fentanyl. Their death rate rose from 0.4 per 100,000 in 2002 to a very high 22.7 per 100,000 by 2022. On the other hand, deaths from natural/semi-synthetic opioids and heroin have staye...	sdg	gretel	summary	open-ended	Aux États-Unis, les décès par surdose d'opioïdes ont augmenté quatre fois depuis 2002, principalement en raison d'opioïdes synthétiques comme le fentanyl. Le taux de décès dus aux opioïdes synthétiques est passé de 0,4 pour 100 000 en 2002 à 22,7 pour 100 000 en 2022. En revanche, les décès dus aux opioïdes naturels/se...	true
861	¿El enfoque de la FDA para combatir la epidemia de opioides implica limitar las recetas de opioides así como promover terapias para el dolor que no son adictivas?	spanish	[ "boolean" ]	question	[ "Infographic", "Table", "Text" ]	[ "Yes, the FDA's approach to combating the opioid epidemic involves limiting opioid prescriptions as well as promoting therapies for pain that are not addictive." ]	sdg	gretel	summary	boolean	Sí, el enfoque de la FDA para combatir la epidemia de opioides implica limitar las recetas de opioides, como a través de pautas de prescripción adecuadas, mientras promueve también terapias para el dolor que no son adictivas, como fomentar el desarrollo de terapias de tratamiento del dolor novedosas.	true
1,170	Confronta i criteri di presentazione per un file ts.xpt completo e un file ts.xpt minimo nelle sottomissioni elettroniche alla FDA per i dati di studi non clinici.	italian	[ "compare-contrast", "extractive" ]	instruction	[ "Infographic", "Table", "Text" ]	[ "The submission criteria for a complete (full) ts.xpt file in FDA electronic submissions for nonclinical study data is that it should accompany SEND datasets, and it must follow the CDISC standards. Meanwhile, the criteria say that a minimal (simplified) ts.xpt file should be sent when a full SEND dataset is not re...	sdg	gretel	summary	compare-contrast	Un file ts.xpt completo accompagna i dataset SEND e segue lo Standard CDISC pubblicato. Un file ts.xpt semplificato viene utilizzato quando i dataset SEND non sono richiesti per le sottomissioni nei Moduli 4.2.3.1, 4.2.3.2 o 4.2.3.4, e quando si utilizza un tag di file STF come pre-clinical-study-report, legacy-clinica...	true
2,144	Analysieren Sie den Zusammenhang zwischen den Janus-nichtklinischen und Kickstart-Diensten und geben Sie die Anzahl der im Jahr 2019 für beide Dienste geladenen/übermittelten Anwendungen an.	german	[ "multi-hop", "numerical" ]	instruction	[ "Chart", "Infographic", "Text" ]	[ "From the information available in the PDF, Janus Nonclinical is a database and system that allows reviewers to use SEND datasets for their reviews. Every SEND study received in an application goes through the Janus loading process automatically. Reviewers may request a Kickstart Service to help them with their app...	human	null	image	multi-hop	Janus Nonclinical ist ein Datenbanksystem, das Rezensenten ermöglicht, SEND-Datensätze für ihre Rezensionen zu verwenden, und Kickstart ist ein Dienst, den OCS anbietet, um Rezensenten bei ihren Anwendungen in Janus Nonclinical zu unterstützen. Im Jahr 2019 wurden 539 Anwendungen und 1359 Studien in Janus Nonclinical g...	true
1,368	In welchem Jahr wurden die Kefauver-Harris Amendments verabschiedet, um randomisierte kontrollierte Studien zum Standard für die Bewertung der klinischen Wirksamkeit zu machen?	german	[ "extractive", "numerical" ]	question	[ "Image", "Text" ]	[ "In 1962, the Kefauver-Harris Amendments were passed to make randomized controlled trials the standard for evaluating the clinical efficacy of new drugs." ]	sdg	custom_pipeline	summary	extractive	Die Kefauver-Harris-Amendments wurden 1962 verabschiedet, um randomisierte kontrollierte Studien zum Standard für die Bewertung der klinischen Wirksamkeit zu machen.	true
109	FDA regulatory incentives for abuse-deterrent opioid formulations	english	[ "extractive" ]	keyword	[ "Infographic", "Table", "Text" ]	[ "The FDA regulatory incentives for abuse-deterrent opioid formulations includes issuing guidances for product developers to facilitate the development of new treatments, develop warnings and safety information for (IR) opioid labeling, strengthen post-market requirements to get the needed data, regulatory activitie...	sdg	gretel	summary	extractive	The FDA regulatory incentives for abuse-deterrent opioid formulations include issuing guidances for product developers, conducting sponsor discussions, expanding the use of advisory committees, and developing warnings and safety information for immediate-release opioid labeling.	true
298	Naloxone vs. Medication Assisted Treatment (MAT)	english	[ "compare-contrast" ]	keyword	[ "Image", "Table", "Text" ]	[ "The FDA has different approaches to support MAT and Naloxone as a treatment for Opioid Use Disorder. For Naloxone, the FDA has aimed to conduct studies to facilitate the switch from prescription to OTC naloxone, which will increase its excess as an intervention measure. Meanwhile, to promote the development of MAT...	human	null	image	compare-contrast	The FDA supports Naloxone by exploring ways to expand access and facilitate the switch from prescription to OTC naloxone, including a labeling study. For Medication Assisted Treatment (MAT), the FDA facilitates the development of new options, promotes the widespread use of existing FDA-approved therapies, and collabora...	true
1,296	Significato dei rapporti sulla sicurezza dei farmaci nel funzionamento della US FDA	italian	[ "open-ended" ]	keyword	[ "Image", "Infographic", "Text" ]	[ "The significance of medication safety reports is that to improve transparency and access to adverse events associated with drug and biologic products for consumers, providers, and researchers, as well as help patients and providers make safe use of drug and biologic products." ]	human	null	image	open-ended	I rapporti sulla sicurezza dei farmaci sono significativi nel funzionamento della US FDA poiché vengono utilizzati per la farmacovigilanza, inclusa l'identificazione di nuovi e potenziali rischi, e fanno parte dei requisiti normativi per le revisioni di sicurezza, anche se il valore di queste revisioni è stato messo in...	true
990	Describa el proceso para que un biosimilar obtenga aprobación mediante la vía 351(k).	spanish	[ "open-ended" ]	instruction	[ "Chart", "Infographic", "Text" ]	[ "The 351(k) pathway for biosimilar approval is a streamlined process that relies on demonstrating \"biosimilarity\" to an existing FDA-approved reference product. The process involves extensive analytical studies, animal studies, and limited clinical studies to show that the biosimilar is highly similar to the refe...	human	null	summary	open-ended	La vía 351(k) para la aprobación de biosimilares es un proceso simplificado que se basa en demostrar la 'biosimilitud' a un producto de referencia aprobado por la FDA. El proceso implica estudios analíticos extensos, estudios en animales y estudios clínicos limitados para mostrar que el biosimilar es altamente similar ...	true
228	Does 'unit-of-use packaging' improve opioid analgesic safety?	english	[ "boolean" ]	question	[ "Infographic", "Table", "Text" ]	[ "Yes, 'unit-of-use packaging' does improve opioid analgesic safety.", "Yes, the \"unit-of-use packaging\" is used as a strategy to improve opioid analgesic safety." ]	human	null	image	boolean	Yes, 'unit-of-use packaging' is used as a strategy to improve opioid analgesic safety.	true
1,886	Analise como os imperativos morais da FDA equilibram a supervisão regulatória com a inovação médica, considerando seu contexto histórico e implicações éticas.	portuguese	[ "open-ended" ]	instruction	[ "Image", "Text" ]	[ "The FDA balances regulatory oversight with medical innovation by protecting the public from harm, ensuring safety and efficacy, and promoting consistent rules while also helping to speed innovations that make medicines safer, more effective, and affordable. Historical crises like elixir sulfanilamide and thalidomi...	sdg	custom_pipeline	summary	open-ended	A FDA equilibra a supervisão regulatória com a inovação médica protegendo o público contra danos, garantindo segurança e eficácia, e promovendo regras consistentes enquanto também ajuda a acelerar inovações que tornam os medicamentos mais seguros, mais eficazes e acessíveis. Crises históricas como o elixir de sulfanila...	true
771	Explique cómo el uso del color y la tipografía en la etiquetación de medicamentos influye en la probabilidad de errores de medicación.	spanish	[ "open-ended" ]	instruction	[ "Image", "Infographic", "Other", "Table", "Text" ]	[ "Explicitly mentioned \"SAFETY CONSIDERATIONS FOR CONTAINER LABELS AND CARTON LABELING TO MINIMIZE MEDICATION ERRORS,\" indicating the focus on reducing errors through typography and color. Using techniques such as proper boxing, color differentiation, prominent typeface/type weight, at least a 12-point sans-serif ...	sdg	gretel	summary	open-ended	El uso del color y la tipografía en la etiquetación de medicamentos influye en la probabilidad de errores de medicación al mejorar la legibilidad y diferenciar la información crítica. Para minimizar errores, la FDA recomienda usar al menos una fuente sans-serif de 12 puntos, asegurando un contraste adecuado entre los c...	true
640	Naloxone contre le traitement médicamenteux assisté (MAT)	french	[ "compare-contrast" ]	keyword	[ "Image", "Table", "Text" ]	[ "The FDA has different approaches to support MAT and Naloxone as a treatment for Opioid Use Disorder. For Naloxone, the FDA has aimed to conduct studies to facilitate the switch from prescription to OTC naloxone, which will increase its excess as an intervention measure. Meanwhile, to promote the development of MAT...	human	null	image	compare-contrast	La FDA soutient la naloxone en explorant des moyens d'élargir l'accès et de faciliter le passage de la naloxone sur ordonnance à la naloxone en vente libre, y compris une étude d'étiquetage. Pour le traitement assisté par médicament (MAT), la FDA facilite le développement de nouvelles options, promeut l'utilisation gén...	true
1,365	Spiega come il passaggio da GDUFA I a GDUFA II illustri la strategia in evoluzione della FDA per gestire le revisioni dei farmaci generici di fronte all'aumento della complessità, delle inefficienze e dell'espansione globale.	italian	[ "open-ended" ]	instruction	[ "Chart", "Infographic", "Table", "Text" ]	[ "The shift from GDUFA I to GDUFA II illustrates a change in the FDA's strategy from simply addressing a review backlog to implementing a more comprehensive framework that improves review efficiency, communication, and predictability. This new approach directly tackled rising complexities in drug products and the ch...	human	null	summary	open-ended	Il passaggio da GDUFA I a GDUFA II illustra la strategia in evoluzione dell'FDA per affrontare la crescente complessità delle domande di farmaci generici e le sfide di un panorama di produzione globale in crescita. Mentre GDUFA I ha stabilito un nuovo quadro per revisioni tempestive, GDUFA II costruisce su questa base ...	true
1,104	Spiega come il modello piramidale gerarchico supporta il processo di approvazione dei biosimilari da parte della FDA.	italian	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The FDA’s biosimilar approval process requires a 351(k) application with adequate data showing the proposed product is highly similar to the US-licensed reference product, allowing for minor differences in inactive components. Analytical data, being more sensitive than clinical data, forms the foundation for detec...	sdg	custom_pipeline	summary	open-ended	Il modello a piramide gerarchica supporta il processo di approvazione dei biosimilari della FDA stabilendo un approccio a livelli in cui i dati analitici costituiscono la base, seguiti da studi sugli animali, farmacologia clinica e studi clinici aggiuntivi. Questo modello richiede una domanda 351(k) che dimostri che il...	true
81	opioid crisis trends synthetic vs prescription opioids 2000 to 2022	english	[ "compare-contrast", "open-ended" ]	keyword	[ "Chart", "Infographic", "Text" ]	[ "In the U.S., opioid overdose deaths have increased fourfold since 2002. This big jump is mainly because of synthetic opioids like fentanyl. Their death rate rose from 0.4 per 100,000 in 2002 to a very high 22.7 per 100,000 by 2022. On the other hand, deaths from natural/semi-synthetic opioids and heroin have staye...	sdg	gretel	summary	open-ended	In the U.S., opioid overdose deaths have increased fourfold since 2002, primarily due to synthetic opioids like fentanyl. The death rate from synthetic opioids rose from 0.4 per 100,000 in 2002 to 22.7 per 100,000 in 2022. In contrast, deaths from natural/semi-synthetic opioids and heroin have remained stable or decrea...	true
2,090	Quels sont les niveaux dans l'identification et l'analyse des risques actifs, et comment le système ARIA est-il lié à l'exigence de considérer sa suffisance avant la PMR ?	french	[ "enumerative", "multi-hop" ]	question	[ "Infographic", "Text" ]	[ "The levels in Active Risk Identification Analysis comprised three levels: Level 1 - Descriptive Analyses and Unadjusted Rates, Level 2 - Adjusted Analysis with Sophisticated Confounding Control, and Level 3 - Sequential Adjusted Analyses with Sophisticated Confounding Control. The FDA must assess ARIA's sufficienc...	human	null	image	multi-hop	Les niveaux dans l'Identification et l'Analyse du Risque Actif sont : Tableau Résumé (ST) - Comptages simples, Niveau 1 (L1) - Analyses descriptives complexes, et Niveau 2 (L2) - Analyses inférentielles. Le système ARIA est lié à la exigence de considérer sa suffisance avant le PMR, car la Section 905 mandate la créati...	true
1,445	Erklären Sie die Faktoren, die von Regulierungsbehörden bei der Bewertung von Arzneimittelnamen hinsichtlich potenzieller Verwechslungsrisiken berücksichtigt werden.	german	[ "open-ended" ]	instruction	[ "Image", "Infographic", "Table", "Text" ]	[ "Factors considered by regulatory agencies when evaluating drug names for potential confusion risks are:\nSpelling of the name\nPronunciation of the name\nAppearance of the name when scripted (handwritten or in a computer system).", "Regulatory agencies assess drug name confusion risk by reviewing reports of look...	sdg	custom_pipeline	summary	open-ended	Faktoren, die von regulatorischen Behörden bei der Bewertung von Arzneimittelnamen auf potenzielle Verwechslungsrisiken berücksichtigt werden, sind: Schreibweise des Namens, Aussprache des Namens und Erscheinung des Namens bei handschriftlicher Darstellung.	true
970	¿Cómo ayuda REMS a gestionar la crisis de opioides?	spanish	[ "open-ended" ]	question	[ "Infographic", "Table", "Text" ]	[ "REMS helps manage the opioid crisis by requiring drug companies producing Extended-Release Long-Acting opioids to fund prescriber education on safe use. The FDA held a public meeting in May 2017 and issued REMS letters in September 2017 to extend training to prescribers of IR opioids. The FDA plans to expand REMS ...	human	null	summary	open-ended	REMS ayuda a gestionar la crisis de opioides al requerir que las empresas farmacéuticas que producen opioides de liberación extendida de acción prolongada financien programas de educación continua para los prescriptores. La FDA celebró una reunión pública en mayo de 2017 y emitió cartas REMS en septiembre de 2017 para ...	true
761	Explique los factores considerados por las agencias reguladoras al evaluar los nombres de medicamentos para riesgos de confusión potencial.	spanish	[ "open-ended" ]	instruction	[ "Image", "Infographic", "Table", "Text" ]	[ "Factors considered by regulatory agencies when evaluating drug names for potential confusion risks are:\nSpelling of the name\nPronunciation of the name\nAppearance of the name when scripted (handwritten or in a computer system).", "Regulatory agencies assess drug name confusion risk by reviewing reports of look...	sdg	custom_pipeline	summary	open-ended	Factores considerados por las agencias reguladoras al evaluar nombres de medicamentos para riesgos de confusión potenciales son: ortografía del nombre, pronunciación del nombre, y apariencia del nombre cuando está escrito.	true
625	Quel est l'objectif du fichier simplifié ts.xpt ?	french	[ "open-ended" ]	question	[ "Image", "Table", "Text" ]	[ "The simplified ts.xpt file is used when SEND datasets are not required for submissions in specific modules and with specific STF tags as an alternative to the full ts.xpt file. The agency also encourages the use of simplified tx.xpt prior to the activation of technical rejection." ]	human	null	summary	open-ended	Le fichier ts.xpt simplifié est utilisé lorsque les jeux de données SEND ne sont pas requis pour les soumissions dans des modules spécifiques (4.2.3.1, 4.2.3.2, 4.2.3.4) et avec des balises de fichier STF spécifiques (pre-clinical-study-report, legacy-clinical-study-report, study-report-body), et l'agence encourage son...	true
364	Exigences de la FDA pour prouver l'interchangeabilité des biosimilaires par la méthodologie des études de basculement	french	[ "open-ended" ]	keyword	[ "Infographic", "Text" ]	[ "It was mentioned that data to support approval of an interchangeable product includes demonstrating biosimilarity, along with additional requirements outlined by statute. These include showing that the product is expected to produce the same clinical result as the reference product in all licensed conditions of us...	sdg	gretel	summary	open-ended	Pour prouver l'interchangeabilité du biosimilaire, la FDA exige des données démontrant la biosimilarité et des exigences supplémentaires, y compris la démonstration que le produit peut être attendu pour produire le même résultat clinique que le produit de référence dans toutes les conditions d'utilisation autorisées, g...	true
390	Quelles améliorations GDUFA II a-t-elle mises en œuvre pour rationaliser le processus d'approbation des médicaments génériques, et comment ces changements influencent-ils les rôles et obligations tant des promoteurs que de la FDA ?	french	[ "open-ended" ]	question	[ "Chart", "Image", "Infographic", "N/A (If relevance score=0)", "Text" ]	[ "The enhancements implemented by GDUFA II are DCAP, the Pre-ANDA Program for Complex Products, \"PFC\" (Pre-submission Facility Correspondence), DMF Enhancements, Accountability and reporting enhancement, reducing approval cycles and the small business relief. These changes make the FDA more transparent, while the ...	sdg	gretel	summary	open-ended	GDUFA II a mis en œuvre plusieurs améliorations pour rationaliser le processus d'approbation des médicaments génériques, y compris le programme Pre-ANDA pour les produits complexes, qui fournit aux promoteurs des réunions, des délais et des orientations spécifiques au produit pour résoudre les problèmes précocement. Il...	true
1,240	Come sta affrontando la FDA le carenze di farmaci e i problemi normativi nel settore farmaceutico?	italian	[ "open-ended" ]	question	[ "Chart", "Image", "Infographic", "Text" ]	[ "The FDA addresses drug shortages by managing manufacturing capacity shortfalls. The FDA also addresses drug shortages through continuous inspections domestically and abroad. It leverages various tools for facility assessment, including remote assessment. Early Notification is key to preventing drug shortages. Drug...	human	null	summary	open-ended	La FDA affronta le carenze di farmaci e le questioni normative affrontando le carenze di capacità produttiva, conducendo ispezioni continue a livello nazionale e all'estero (inclusi valutazioni a distanza) e sottolineando la notifica e la comunicazione precoci con l'industria per prevenire le carenze.	true
1,094	In che modo l'approccio della FDA alle carenze di farmaci è cambiato dal 2011 a oggi, e quali fattori hanno contribuito ai miglioramenti nella disponibilità dei farmaci?	italian	[ "open-ended" ]	question	[ "Infographic", "Text" ]	[ "The FDA's approach to drug shortages has evolved from 250 CDER cases in 2011 to the less than 50 cases for CDER and CBER in 2017.\nFactors that have contributed to improvements in drug availability are :\n- prevention to reduce it, market assessment, strategies to address shortages\n- Memorandum of understanding w...	sdg	gretel	summary	open-ended	L'approccio della FDA alle carenze di farmaci è evoluto da 250 casi del CDER nel 2011 a meno di 50 casi per CDER e CBER nel 2017. I fattori che hanno contribuito ai miglioramenti nella disponibilità dei farmaci includono strategie di prevenzione, valutazioni di mercato, un Memorandum d'Intesa con la DEA, la Task Force ...	true
1,026	In quale anno gli emendamenti Kefauver-Harris sono stati approvati per rendere i trial clinici randomizzati controllati lo standard per la valutazione dell'efficacia clinica?	italian	[ "extractive", "numerical" ]	question	[ "Image", "Text" ]	[ "In 1962, the Kefauver-Harris Amendments were passed to make randomized controlled trials the standard for evaluating the clinical efficacy of new drugs." ]	sdg	custom_pipeline	summary	extractive	Le Emendamenti Kefauver-Harris furono approvati nel 1962 per rendere i trial controllati randomizzati lo standard per valutare l'efficacia clinica.	true
1,135	Incentivi normativi FDA per formulazioni di oppioidi con deterrenza all'abuso	italian	[ "extractive" ]	keyword	[ "Infographic", "Table", "Text" ]	[ "The FDA regulatory incentives for abuse-deterrent opioid formulations includes issuing guidances for product developers to facilitate the development of new treatments, develop warnings and safety information for (IR) opioid labeling, strengthen post-market requirements to get the needed data, regulatory activitie...	sdg	gretel	summary	extractive	Gli incentivi normativi della FDA per le formulazioni oppioidi con deterrenza all'abuso includono l'emissione di linee guida per gli sviluppatori di prodotti, la conduzione di discussioni con i sponsor, l'espansione dell'uso dei comitati consultivi e lo sviluppo di avvertimenti e informazioni sulla sicurezza per l'etic...	true
1,740	Analise as implicações do CBD Work Plan da FDA sobre futuras regulamentações de produtos de cannabis.	portuguese	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The FDA's CBD Work Plan signals a shift toward a science-driven, transparent, and flexible regulatory framework for cannabis products. It emphasizes developing a comprehensive research agenda to fill safety and efficacy data gaps, exploring new regulatory pathways beyond traditional drug classification, potentiall...	sdg	custom_pipeline	summary	open-ended	O Plano de Trabalho da FDA sobre CBD implica uma mudança em direção a um quadro regulatório baseado na ciência, transparente e flexível para produtos de cannabis. Inclui desenvolver uma agenda de pesquisa abrangente para abordar lacunas de dados, avaliar novas vias regulatórias para produtos de CBD além da classificaçã...	true
1,913	Quais são os três tipos de estimativas de redução da FDA com base na quantidade de empréstimo?	portuguese	[ "enumerative", "extractive" ]	question	[ "Infographic" ]	[ "The three types of FDA shrinkage estimates based on the amount of borrowing are:\nSample Estimate: This corresponds to no borrowing.\nShrinkage Estimate: This corresponds to some borrowing.\nOverall Estimate: This corresponds to 100% borrowing." ]	human	null	image	enumerative	Os três tipos de estimativas de encolhimento da FDA com base na quantidade de empréstimo são: Estimativa da Amostra (sem empréstimo), Estimativa de Encolhimento (algum empréstimo) e Estimativa Geral (100% de empréstimo).	true
2,173	Como as orientações e regras da FDA sobre condições insalubres e manuseio de produtos biológicos refletem suas prioridades de saúde pública?	portuguese	[ "multi-hop" ]	question	[ "Image", "Infographic", "Text" ]	[ "The FDA guidelines focus on:\n1. Address significant public health concerns, \n2. Provide clarification on provisions of the law and answer questions presented by stakeholders,\n3. Decrease regulatory burden to the extent possible without sacrificing critical public health protections,\n4. Clarify the responsibili...	human	null	image	multi-hop	A orientação e as regras da FDA sobre condições insalubres e manipulação de produtos biológicos refletem suas prioridades de saúde pública ao abordar preocupações significativas de saúde pública, fornecendo esclarecimento sobre disposições legais, reduzindo a carga regulatória sem sacrificar proteções críticas e esclar...	true
1,733	Quais workshops e fóruns específicos a FDA realizou para enfrentar problemas no desenvolvimento de medicamentos genéricos, e quais foram as áreas de ênfase individuais de cada um?	portuguese	[ "enumerative" ]	question	[ "Image", "Text" ]	[ "-In April 2021, Generic Drug Forum 2021: Lifecycle of a Generic Drug.\n-In June 2021, Generic Drug Regulatory Science Initiatives Public Workshop.\n-In August 2021, IVRT and IVPT Methods: Best practices and scientific considerations for ANDA submission\n-In September 2021, Advancing Generic Drug Development: Trans...	sdg	custom_pipeline	summary	enumerative	Em abril de 2021, a FDA realizou o Fórum de Medicamentos Genéricos 2021: Ciclo de Vida de um Medicamento Genérico. Em junho de 2021, foi realizada a Oficina Pública das Iniciativas de Ciência Regulatória de Medicamentos Genéricos. Em agosto de 2021, ocorreu a oficina Métodos IVRT e IVPT: Melhores práticas e consideraçõ...	true
1,765	Requisitos do processo de aprovação de biossimilares da FDA pelo caminho 351(k)	portuguese	[ "enumerative", "open-ended" ]	keyword	[ "Infographic", "Text" ]	[ "The FDA's 351(k) biosimilar approval pathway is an abbreviated process that requires a proposed product to demonstrate \"biosimilarity\" to a reference product. This is accomplished by showing the biological product is \"highly similar\" with no clinically meaningful differences in terms of safety, purity, and pot...	sdg	gretel	summary	open-ended	O caminho de aprovação biossimilar da FDA 351(k) é um processo abreviado que exige que um produto proposto demonstre "biossimilaridade" a um produto de referência. Isso é alcançado mostrando que o produto biológico é "altamente similar" sem diferenças clinicamente significativas em termos de segurança, pureza e potênci...	true
1,490	Beschreiben Sie, wie die FDA die Doppelherausforderung bewältigt, den Missbrauch von Opioiden zu verhindern und gleichzeitig eine ausreichende Verfügbarkeit von injizierbaren Opioiden in medizinischen Einrichtungen sicherzustellen, und erläutern Sie die im Text genannten spezifischen Maßnahmen.	german	[ "open-ended" ]	instruction	[ "Chart", "Infographic", "N/A (If relevance score=0)", "Other", "Table", "Text" ]	[ "The FDA manages the dual challenge of preventing opioid misuse while ensuring sufficient availability of injectable opioids in medical settings by:\n1. Decreasing Exposure and Prevent New Addiction.\n2. Supporting the Treatment of those with Opioid use disorder.\n3. Fostering the Development of Novel pain treatmen...	sdg	custom_pipeline	summary	open-ended	Die FDA bewältigt die doppelte Herausforderung, den Missbrauch von Opioiden zu verhindern, während sie die ausreichende Verfügbarkeit von injizierbaren Opioiden in medizinischen Einrichtungen sicherstellt, indem sie die Prüfung neuer Produktanträge beschleunigt, die vorübergehende Einfuhr nicht zugelassener Produkte zu...	true
887	¿Cuáles son los tres tipos de estimaciones de contracción de la FDA según la cantidad de préstamo?	spanish	[ "enumerative", "extractive" ]	question	[ "Infographic" ]	[ "The three types of FDA shrinkage estimates based on the amount of borrowing are:\nSample Estimate: This corresponds to no borrowing.\nShrinkage Estimate: This corresponds to some borrowing.\nOverall Estimate: This corresponds to 100% borrowing." ]	human	null	image	enumerative	Los tres tipos de estimaciones de contracción de la FDA basadas en la cantidad de préstamo son: Estimación de la muestra (ningún préstamo), Estimación de contracción (algún préstamo) y Estimación general (100% de préstamo).	true
397	processus d'approbation des biosimilaires par la FDA, exigences de la voie 351(k)	french	[ "enumerative", "open-ended" ]	keyword	[ "Infographic", "Text" ]	[ "The FDA's 351(k) biosimilar approval pathway is an abbreviated process that requires a proposed product to demonstrate \"biosimilarity\" to a reference product. This is accomplished by showing the biological product is \"highly similar\" with no clinically meaningful differences in terms of safety, purity, and pot...	sdg	gretel	summary	open-ended	La voie d'approbation des biosimilaires 351(k) de la FDA est un processus abrégé qui exige que le produit proposé démontre une "biosimilarité" avec un produit de référence. Cela est accompli en montrant que le produit biologique est "très similaire" sans différences cliniquement significatives en termes de sécurité, de...	true
129	Contrast the mandatory submission timelines for cardiovascular safety pharmacology studies and developmental and reproductive toxicology studies under FDA's SEND standards	english	[ "compare-contrast", "extractive" ]	instruction	[ "Infographic" ]	[ "The mandatory submission timelines under FDA's SEND standards for Cardiovascular Safety Pharmacology studies is March 19th, 2020 (3-19-2020), and the Rat Fertility and Early Embryonic Development study under the Developmental and Reproductive Toxicology Studies is February 15th, 2015 (2-15-2025)." ]	sdg	custom_pipeline	summary	compare-contrast	Under FDA's SEND standards, the mandatory submission timeline for Cardiovascular Safety Pharmacology studies is March 19th, 2020 (3-19-2020), and for Rat Fertility and Early Embryonic Development studies, it is February 15th, 2015 (2-15-2015).	true
2,162	Como a FDA usou PSGs e colaborações de pesquisa para melhorar os padrões de bioequivalência para genéricos?	portuguese	[ "multi-hop" ]	question	[ "Infographic", "Other" ]	[ "PSG and research collaborations improve bioequivalence standards for generics. In Product-Specific Guidance, which includes scientific advice to assist generic drug product development, such as revisions driven by scientific research, 134 PSGs in FY21, which have 53 (39%) PSGs for complex products, and 20 PSGs pro...	human	null	image	multi-hop	A FDA usou Orientações Específicas de Produto (PSGs) e colaborações de pesquisa para melhorar os padrões de bioequivalência para genéricos. No FY21, 135 PSGs foram publicados, incluindo 53 (39%) para produtos complexos e 20 que forneceram uma abordagem BE mais eficiente. PSGs oferecem aconselhamento científico e são re...	true
1,237	Indicare l'iniziativa intrapresa per affrontare le cause profonde dei problemi di approvvigionamento dei farmaci e sviluppare soluzioni a lungo termine da parte della FDA nel 2018.	italian	[ "extractive" ]	instruction	[ "Image", "Text" ]	[ "The FDA announced the FDA Drug Shortage Taskforce in July 2018 to improve understanding of the forces leading to drug shortages and identify potential solutions. The FDA facilitates temporary and long-term strategies to address shortages and distribute information to maintain availability while minimizing risk to ...	human	null	summary	extractive	Nel luglio 2018, la FDA ha annunciato la Taskforce sulla carenza di farmaci della FDA per migliorare la comprensione delle forze che portano alle carenze di farmaci e identificare soluzioni potenziali. La Taskforce ha tenuto sessioni di ascolto con gli stakeholder con farmacie, ospedali, gruppi di produzione, gruppi me...	true
188	What are the responsibilities managed by the Office of Generic Drugs of the FDA?	english	[ "multi-hop" ]	question	[ "Chart", "Infographic", "Table", "Text" ]	[ "The FDA's Office of Generic Drugs (OGD) is responsible for the full lifecycle of generic drugs. Its duties include reviewing and issuing regulatory actions on Abbreviated New Drug Applications (ANDAs), evaluating drug quality and bioequivalence, and managing all aspects of the GDUFA II program. The OGD also engage...	human	null	summary	open-ended	The FDA's Office of Generic Drugs (OGD) is responsible for the full lifecycle of generic drugs, including reviewing and issuing regulatory actions on Abbreviated New Drug Applications (ANDAs), evaluating drug quality and bioequivalence, managing the GDUFA II program, conducting post-market surveillance, handling drug s...	true
1,043	Secondo le linee guida della FDA, quale è il formato richiesto per indicare la concentrazione di un farmaco parenterale in volume ridotto sull'etichetta?	italian	[ "extractive" ]	question	[ "Image", "Infographic", "Text" ]	[ "According to FDA guidelines, the strength of a small-volume parenteral product must be displayed as\nQuantity per total volume (e.g., 2 g/20 mL)\nImmediately followed, in parentheses, by the quantity per milliliter\nExample format: 2 g/20 mL (100 mg/mL)", "According to FDA guidelines, the required format for dis...	sdg	custom_pipeline	summary	extractive	Secondo le linee guida della FDA, la concentrazione di un farmaco parenterale a piccolo volume deve essere indicata come quantità per volume totale (es. 2 g/20 mL), immediatamente seguita tra parentesi dalla quantità per millilitro (es. 100 mg/mL).	true
1,811	Aprimoramentos da FDA aos programas REMS esforços 2017 2018	portuguese	[ "open-ended" ]	keyword	[ "Image", "Infographic", "Other", "Text" ]	[ "In 2017-2018, the FDA enhanced REMS programs by:\n1. Launching a \"REMS Resources Portal\" for easier access.\n2. Issuing draft guidance for \"shared system REMS\" and \"waivers\" to improve clarity and efficiency.\n3. Releasing a draft guidance on using a \"Drug Master File\" for submissions.\n4. Putting REMS doc...	sdg	gretel	summary	open-ended	Em 2017-2018, a FDA aprimorou os programas REMS por: 1. Lançar um 'Portal de Recursos REMS' para acesso mais fácil. 2. Emitir orientação preliminar para 'REMS de sistema compartilhado' e 'isenções' para melhorar clareza e eficiência. 3. Lançar orientação preliminar sobre o uso de um 'Arquivo Principal de Medicamento' p...	true
1,969	Liste quatro partes da nova abordagem geral da FDA para uma elaboração eficaz de políticas, em relação à comunicação pública, revisões de segurança farmacêutica e vigilância de produtos.	portuguese	[ "enumerative", "extractive" ]	instruction	[ "Infographic", "Text" ]	[ "Four parts of the FDA's overall new approach include:\n1) Improving public communication through stakeholder meetings, sponsor engagement, and patient counseling (Educate, Engage, Evaluate, Ensure).\n2) Strengthening safety reviews with benefit–risk evaluation, modular analytic tools, and streamlined postmarketing...	human	null	summary	extractive	Quatro partes da nova abordagem geral da FDA incluem: 1) Melhorar a comunicação pública por meio de reuniões com partes interessadas, engajamento de patrocinadores e aconselhamento de pacientes (Educar, Engajar, Avaliar, Garantir). 2) Fortalecer as revisões de segurança com avaliação de benefício-risco, ferramentas ana...	true
204	Why does the consent for biosimilar products not depend on basic chemical equivalents?	english	[ "open-ended" ]	question	[ "Image", "Text" ]	[ "Biosimilar products don't need to be exact chemical copies of the original drug for approval. Since they're complex biological products and not simple chemicals, they can't be manufactured as perfect replicas. They must be highly similar to the reference products with no clinically meaningful differences(approval ...	human	null	summary	open-ended	Biosimilar products do not need to be exact chemical copies of the original drug because they are complex biological products that cannot be manufactured as perfect replicas. Instead, they must be highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency.	true
1,559	Warum und wie ist die Principal Display Panel für die Arzneimittelsicherheit wichtig?	german	[ "open-ended" ]	question	[ "Image", "Infographic", "Table", "Text" ]	[ "The Principal Display Panel (PDP) is vital for medication safety as it is the main label seen by users on shelves. To reduce errors, it should use at least 12-point sans-serif font, contrasting text/background, The established name should be half the size of proprietary name, and distinct color schemes per drug. I...	human	null	image	open-ended	Das Hauptanzeigefeld (PDP) ist für die Medikamentensicherheit entscheidend, da es das Hauptetikett ist, das von Benutzern auf Regalen gesehen wird. Um Fehler zu reduzieren, muss es kritische Informationen wie den etablierten Namen, die Stärke, die Verabreichungsroute, den Markennamen, die Darreichungsform und Warnhinwe...	true
2,052	How did the FDA use PSGs and research collaborations to improve bioequivalence standards for generics?	english	[ "multi-hop" ]	question	[ "Infographic", "Other" ]	[ "PSG and research collaborations improve bioequivalence standards for generics. In Product-Specific Guidance, which includes scientific advice to assist generic drug product development, such as revisions driven by scientific research, 134 PSGs in FY21, which have 53 (39%) PSGs for complex products, and 20 PSGs pro...	human	null	image	multi-hop	The FDA used Product-Specific Guidances (PSGs) and research collaborations to improve bioequivalence standards for generics. In FY21, 135 PSGs were published, including 53 (39%) for complex products and 20 that provided a more efficient BE approach. PSGs offer scientific advice and are revised based on science and rese...	true
1,324	Naloxone vs. Trattamento Assistito con Farmaci (MAT)	italian	[ "compare-contrast" ]	keyword	[ "Image", "Table", "Text" ]	[ "The FDA has different approaches to support MAT and Naloxone as a treatment for Opioid Use Disorder. For Naloxone, the FDA has aimed to conduct studies to facilitate the switch from prescription to OTC naloxone, which will increase its excess as an intervention measure. Meanwhile, to promote the development of MAT...	human	null	image	compare-contrast	La FDA supporta la Naloxone esplorando modi per espandere l'accesso e facilitare il passaggio dalla prescrizione alla Naloxone da banco, inclusa uno studio sull'etichettatura. Per il Trattamento Assistito da Farmaci (MAT), la FDA facilita lo sviluppo di nuove opzioni, promuove l'uso diffuso delle terapie già approvate ...	true
1,788	Explique como o modelo de pirâmide hierárquica apoia o processo de aprovação de biossimilares da FDA.	portuguese	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The FDA’s biosimilar approval process requires a 351(k) application with adequate data showing the proposed product is highly similar to the US-licensed reference product, allowing for minor differences in inactive components. Analytical data, being more sensitive than clinical data, forms the foundation for detec...	sdg	custom_pipeline	summary	open-ended	O modelo hierárquico de pirâmide suporta o processo de aprovação de biossimilares da FDA estabelecendo uma abordagem em níveis onde os dados analíticos formam a base, seguidos por estudos em animais, farmacologia clínica e estudos clínicos adicionais. Este modelo exige uma aplicação 351(k) demonstrando que o produto pr...	true
387	De quelle manière la FDA a-t-elle modifié son approche réglementaire pour soutenir l'innovation médicale tout en garantissant la sécurité des patients face à des technologies en rapide évolution telles que la thérapie génique et les solutions de santé numérique ?	french	[ "open-ended" ]	question	[ "Infographic", "Text" ]	[ "The FDA aids innovation by applying regulations with a public health mission, adapting to advances through new authorities and harmonization, and promoting novel therapies. It speeds development via adaptive trials, biomarkers, and targeted meetings, while ensuring safety through pre- and post-market review, inspe...	sdg	custom_pipeline	summary	open-ended	La FDA soutient l'innovation médicale en appliquant des réglementations avec une mission de santé publique, en s'adaptant aux progrès grâce à de nouvelles autorités et à l'harmonisation, et en promouvant des thérapies novatrices. Elle accélère le développement via des essais adaptatifs, des biomarqueurs et des réunions...	true
1,063	Identificare gli elementi principali del programma REMS e spiegare come ciascuno contribuisce al mantenimento della sicurezza del farmaco	italian	[ "enumerative", "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The main elements of the REMS (Risk Evaluation and Mitigation Strategy) program are\nREMS Resources Portal: provides stakeholders with easy access to information.\nREMS and Continuing Education: ensure that healthcare providers are properly informed about a drug's safety risks and management. \nShared System REMS:...	sdg	gretel	summary	enumerative	Gli elementi principali del programma REMS (Risk Evaluation and Mitigation Strategy) sono il REMS Resources Portal, che fornisce agli stakeholder un facile accesso alle informazioni; REMS e Formazione Continua, che garantisce che i professionisti sanitari siano correttamente informati sui rischi per la sicurezza e la g...	true
628	Comment le REMS aide-t-il à gérer la crise des opioïdes ?	french	[ "open-ended" ]	question	[ "Infographic", "Table", "Text" ]	[ "REMS helps manage the opioid crisis by requiring drug companies producing Extended-Release Long-Acting opioids to fund prescriber education on safe use. The FDA held a public meeting in May 2017 and issued REMS letters in September 2017 to extend training to prescribers of IR opioids. The FDA plans to expand REMS ...	human	null	summary	open-ended	REMS aide à gérer la crise des opioïdes en exigeant que les entreprises pharmaceutiques produisant des opioïdes à libération prolongée de longue durée financent des programmes d'éducation continue pour les prescripteurs. La FDA a tenu une réunion publique en mai 2017 et a envoyé des lettres REMS en septembre 2017 pour ...	true
647	Quand les engagements de la FDA au titre du GDUFA II s'appliquent-ils ?	french	[ "extractive" ]	question	[ "Chart", "Infographic", "Text" ]	[ "The FDA's commitments under GDUFA II applied begins on October 1, 2017." ]	human	null	image	extractive	Les engagements de la FDA dans le cadre de GDUFA II s'appliquent aux nouveaux ANDA originaux soumis le 1er octobre 2017 ou après.	true
222	What types of activities is IMEDS used for in enhancing drug safety surveillance?	english	[ "enumerative", "open-ended" ]	question	[ "Image", "Text" ]	[ "IMEDS contributes in the following ways to enhance the drug safety surveillance:\n1) Contributing data to the Distributed Database,\n2) Offer industry, academic, and research access to a system familiar to Sentinel for evaluating safety signals,\n3) Implementing post-market studies,\n4) Assessing the impact of ris...	human	null	summary	enumerative	IMEDS enhances drug safety surveillance by contributing data to the Distributed Database, offering industry, academic, and research access to a system familiar to Sentinel for evaluating safety signals, implementing post-market studies, and assessing the impact of risk management actions.	true
1,000	Aprobación de la FDA de EE. UU. de productos biológicos biosimilares e intercambiables.	spanish	[ "open-ended" ]	keyword	[ "Infographic", "N/A (If relevance score=0)", "Text" ]	[ "U.S. FDA approval of biosimilar and interchangeable (IC) biological products:\n- The products must be manufactured, processed, packed, or held in a facility that meets the same standards.\n- The IC is biosimilar with extra requirements. The FDA approves it based on biosimilar requirements, along with additional cr...	human	null	summary	open-ended	La aprobación de la FDA de EE.UU. de productos biológicos biosimilares e intercambiables (IC) requiere que los productos sean biosimilares al producto de referencia y se pueda esperar que produzcan el mismo resultado clínico en cualquier paciente dado. El producto IC es biosimilar con requisitos adicionales, incluyendo...	true
1,590	Für welche Arten von Aktivitäten wird IMEDS zur Verbesserung der Arzneimittelsicherheitsüberwachung verwendet?	german	[ "enumerative", "open-ended" ]	question	[ "Image", "Text" ]	[ "IMEDS contributes in the following ways to enhance the drug safety surveillance:\n1) Contributing data to the Distributed Database,\n2) Offer industry, academic, and research access to a system familiar to Sentinel for evaluating safety signals,\n3) Implementing post-market studies,\n4) Assessing the impact of ris...	human	null	summary	enumerative	IMEDS verbessert die Arzneimittelsicherheitsüberwachung, indem es Daten zur verteilten Datenbank beiträgt und der Industrie, der Akademie und der Forschung Zugang zu einem für Sentinel vertrauten System zur Bewertung von Sicherheitssignalen, Implementierung von Post-Markt-Studien und Bewertung der Auswirkungen von Risi...	true
25	What steps does the FDA take to ensure biosimilar products are safe and effective before approval?	english	[ "open-ended" ]	question	[ "Infographic", "Text" ]	[ "The steps taken by the FDA to ensure biosimilar products are safe and effective before approval include ensuring that the biosimilar product is highly similar to the reference product approved by PHS and has no clinically meaningful differences, implementing Biologics Price Competition and Innovation Act (BPCI Act...	sdg	gretel	summary	open-ended	The FDA ensures biosimilar products are safe and effective before approval by requiring them to be highly similar to the reference product with no clinically meaningful differences, implementing the Biologics Price Competition and Innovation Act (BPCI Act) which created an abbreviated licensure pathway for biological p...	true
205	How did FDA partnerships complement OGD’s efforts in timely drug reviews and expanding access to first-to-market generics?	english	[ "multi-hop" ]	question	[ "Image", "Infographic", "Text" ]	[ "FDA partnerships complemented OGD’s efforts by offering scientific advice to support generic drug development, driving revisions through research, and publishing 135 PSGs in FY21 (52 for complex products, 20 for efficient BE). This guidance improves transparency and resource use. The Pre-ANDA program reduces devel...	human	null	summary	open-ended	FDA partnerships, through global engagement with entities like the European Medicines Agency, ICH, and international regulators, complemented OGD’s efforts by providing scientific advice via Product-Specific Guidances (PSGs) to support generic drug development, reducing development-to-market time through the Pre-ANDA p...	true
1,173	Quali passaggi ha intrapreso l'Office of Generic Drugs della FDA entro il 2018 per migliorare la trasparenza e la comunicazione con le parti interessate all'interno del programma dei farmaci generici?	italian	[ "open-ended" ]	question	[ "Image", "Table", "Text" ]	[ "The steps taken by the FDA's Office of Generic Drugs by 2018 to enhance transparency and stakeholder communication within the generic drug program are:\n- guidance webinars, reports, and web presence\n- research, projects, and innovation-related podcasts\n- free workshops open to the public" ]	sdg	gretel	summary	open-ended	Entro il 2018, l'Ufficio dei Farmaci Generici della FDA ha migliorato la trasparenza e la comunicazione con le parti interessate implementando una presenza web aggiornata, pubblicando vari rapporti (inclusi rapporti sulle prestazioni, finanziari e trimestrali), conducendo webinar e podcast, e ospitando workshop gratuit...	true
748	¿Se requiere que todos los medicamentos con receta tengan un identificador único de producto según las regulaciones de la DSCSA vigentes en 2023?	spanish	[ "boolean" ]	question	[ "Infographic", "Text" ]	[ "No, not all prescription drugs required to have a unique product identifier. DSCSA aims to track and trace prescription drugs through the supply chain, but not all drugs are required to have a unique product identifier due to various exemptions and exceptions to the rules." ]	sdg	gretel	summary	boolean	No, no todos los medicamentos con receta están obligados a tener un identificador único del producto según las regulaciones DSCSA vigentes en 2023, ya que existen exenciones y excepciones al requisito.	true
281	Explain how the Drug Supply Chain Security Act will be advanced by the Office of Drug Security by 2023 to secure the drug supply chain.	english	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The Drug Supply Chain Security Act aims to develop an electronic, interoperable system by 2023 to secure the drug supply chain. It facilitates the exchange of information by trading partners, improves the efficiency of recalls, enables prompt response to suspect and illegitimate products, and creates transparency ...	human	null	summary	open-ended	The Office of Drug Security will advance the Drug Supply Chain Security Act by achieving its goal of developing an electronic, interoperable system by 2023 to identify and trace prescription drugs at the package level. This system will facilitate information exchange among trading partners, improve the efficiency of re...	true
1,980	Significado dos relatórios de segurança de medicamentos no funcionamento da US FDA	portuguese	[ "open-ended" ]	keyword	[ "Image", "Infographic", "Text" ]	[ "The significance of medication safety reports is that to improve transparency and access to adverse events associated with drug and biologic products for consumers, providers, and researchers, as well as help patients and providers make safe use of drug and biologic products." ]	human	null	image	open-ended	Relatórios de segurança de medicamentos são significativos no funcionamento da US FDA pois são usados para farmacovigilância, incluindo a identificação de novos e potenciais riscos, e fazem parte dos requisitos regulatórios para revisões de segurança, embora o valor dessas revisões tenha sido questionado.	true
458	Expliquez le symbolisme des trois flèches entrelacées dans le cadre réglementaire de la FDA	french	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The symbolism of the three interlocking arrows in the FDA's regulatory framework illustrates their interconnectedness, representing a continuous cycle. It started with the pre-market review, followed by product safety and compliance, and lastly, Consumer & Patient Safety Post-marketing." ]	sdg	custom_pipeline	summary	open-ended	Le symbolisme des trois flèches entrelacées dans le cadre réglementaire de la FDA illustre leur interconnexion, représentant un cycle continu. Il commence par l'Examen Pré-commercialisation, suivi de la Sécurité et de la Conformité du Produit, et enfin, la Sécurité des Consommateurs et des Patients Post-commercialisati...	true
1,577	Wie unterscheidet sich der Ansatz von ISMP zur Fehlermeldung von dem der FDA?	german	[ "compare-contrast" ]	question	[ "Infographic", "Other", "Text" ]	[ "FDA’s error reporting: The FDA responds to reported medication errors by enforcing labeling and packaging changes and issuing urgent advisories via the National Alert Network to quickly inform healthcare providers and stakeholders. \nISMP’s error reporting: Focuses on early warnings, shared learning of information...	human	null	summary	compare-contrast	ISMPs Ansatz zur Fehlerberichterstattung konzentriert sich auf das Sammeln und Teilen von anonymisierten Medikationsfehlerberichten, um landesweite Gefahrenwarnungen herauszugeben, Informationen und Werkzeuge zu verbreiten und für nationale Sicherheitsstandards zu plädieren, um Änderungen bei der Produktbenennung, Kenn...	true
1,798	Quais são os componentes principais e os objetivos da Iniciativa Sentinel da FDA para vigilância de segurança de medicamentos após a comercialização?	portuguese	[ "open-ended" ]	question	[ "Image", "Infographic", "Text" ]	[ "The FDA's Sentinel Initiative is a distributed data system designed to monitor the safety of medical products after they are marketed. Over 178 million people's real-world data are used & partners maintain physical control over their data. Reusable programming tools, a common data model, and the Active Post mark...	sdg	gretel	summary	open-ended	A Iniciativa Sentinel da FDA é um sistema nacional de monitoramento de produtos médicos, um sistema de dados distribuído que usa dados de 17 parceiros com 178 milhões de membros, onde os parceiros de dados mantêm controle físico para proteger a privacidade e a segurança. Componentes-chave incluem ferramentas de program...	true
2,035	Explique o papel dos sistemas de verificação nos termos da DSCSA para manter a segurança da cadeia de suprimentos de medicamentos e o papel das representações visuais no apoio à conformidade e à confiança pública.	portuguese	[ "multi-hop" ]	instruction	[ "Image", "Infographic", "Text" ]	[ "The role of verification systems under the DSCSA is to prevent harmful drugs from entering the supply chain, detect harmful drugs if they enter the supply chain, and respond rapidly when harmful drugs are found. The role of visual representations is to streamline verification and compliance processes and support p...	human	null	summary	multi-hop	O papel dos sistemas de verificação sob a DSCSA é prevenir medicamentos nocivos de entrarem na cadeia de suprimentos, detectar medicamentos nocivos se eles entrarem na cadeia de suprimentos e responder rapidamente quando medicamentos nocivos forem encontrados. O papel das representações visuais, como identificadores de...	true
1,214	Quali sono le responsabilità gestite dall'Office of Generic Drugs della FDA?	italian	[ "multi-hop" ]	question	[ "Chart", "Infographic", "Table", "Text" ]	[ "The FDA's Office of Generic Drugs (OGD) is responsible for the full lifecycle of generic drugs. Its duties include reviewing and issuing regulatory actions on Abbreviated New Drug Applications (ANDAs), evaluating drug quality and bioequivalence, and managing all aspects of the GDUFA II program. The OGD also engage...	human	null	summary	open-ended	L'Ufficio dei Farmaci Generici della FDA (OGD) è responsabile dell'intero ciclo di vita dei farmaci generici, inclusa la revisione e l'emissione di azioni regolatorie sulle Domande Abbreviate di Nuovo Farmaco (ANDA), la valutazione della qualità e della bioequivalenza dei farmaci, la gestione del programma GDUFA II, la...	true
214	How is the FDA tackling drug shortages and regulatory issues in the pharmaceutical sector?	english	[ "open-ended" ]	question	[ "Chart", "Image", "Infographic", "Text" ]	[ "The FDA addresses drug shortages by managing manufacturing capacity shortfalls. The FDA also addresses drug shortages through continuous inspections domestically and abroad. It leverages various tools for facility assessment, including remote assessment. Early Notification is key to preventing drug shortages. Drug...	human	null	summary	open-ended	The FDA tackles drug shortages and regulatory issues by addressing manufacturing capacity shortfalls, conducting continuous inspections domestically and abroad (including remote assessments), and emphasizing early notification and communication with the industry to prevent shortages.	true
1,150	Quali ragioni spiegano la distinzione della FDA tra CBD e THC derivati dalla cannabis e componenti derivati dai semi di canapa nelle sue politiche di regolamentazione alimentare?	italian	[ "open-ended" ]	question	[ "Infographic", "Text" ]	[ "According to the FDA, CBD and THC products are excluded from the definition of dietary supplements under the FD&C Act. It is because CBD and THC are active ingredients in drug products that are studied and approved for use in medicines. FDA completed the evaluation of three GRAS notices related to the use of hemp ...	sdg	custom_pipeline	summary	open-ended	La FDA distingue tra il CBD e il THC derivati dalla cannabis e i componenti derivati dai semi di canapa perché il CBD e il THC sono ingredienti attivi in prodotti farmaceutici approvati, rendendoli inidonei all'uso negli alimenti e negli integratori alimentari ai sensi della legge FD&C. Al contrario, ingredienti deriva...	true
430	Quelles sont les composantes clés et les objectifs de l'initiative Sentinel de la FDA pour la surveillance de la sécurité des médicaments après leur mise sur le marché ?	french	[ "open-ended" ]	question	[ "Image", "Infographic", "Text" ]	[ "The FDA's Sentinel Initiative is a distributed data system designed to monitor the safety of medical products after they are marketed. Over 178 million people's real-world data are used & partners maintain physical control over their data. Reusable programming tools, a common data model, and the Active Post mark...	sdg	gretel	summary	open-ended	L'initiative Sentinel de la FDA est un système national de surveillance des produits médicaux, un système de données distribuées qui utilise des données provenant de 17 partenaires ayant 178 millions de membres, où les partenaires de données conservent le contrôle physique pour protéger la vie privée et la sécurité. Le...	true
1,609	Ist es richtig, dass die MERP von ISMP es Benutzern erlaubt, beim Einreichen des Berichts das Bild des Produkts hochzuladen?	german	[ "boolean" ]	question	[ "Infographic", "Text" ]	[ "Yes, MERP by ISMP allows users to upload the image of the product while filing the report." ]	human	null	image	boolean	Ja, MERP von ISMP ermöglicht es Benutzern, das Bild des Produkts hochzuladen, während sie den Bericht einreichen.	true
1,758	Quais aprimoramentos o GDUFA II implementou para agilizar o processo de aprovação de medicamentos genéricos, e como essas mudanças impactam os papéis e obrigações tanto dos patrocinadores quanto da FDA?	portuguese	[ "open-ended" ]	question	[ "Chart", "Image", "Infographic", "N/A (If relevance score=0)", "Text" ]	[ "The enhancements implemented by GDUFA II are DCAP, the Pre-ANDA Program for Complex Products, \"PFC\" (Pre-submission Facility Correspondence), DMF Enhancements, Accountability and reporting enhancement, reducing approval cycles and the small business relief. These changes make the FDA more transparent, while the ...	sdg	gretel	summary	open-ended	GDUFA II implementou várias melhorias para agilizar o processo de aprovação de medicamentos genéricos, incluindo o programa Pre-ANDA para produtos complexos, que fornece aos patrocinadores reuniões, prazos e orientações específicas do produto para resolver problemas precocemente. Também introduziu "PFC" (Pre-submission...	true
1,048	Requisiti FDA per dimostrare l'intercambiabilità dei biosimilari attraverso la metodologia degli studi di switch	italian	[ "open-ended" ]	keyword	[ "Infographic", "Text" ]	[ "It was mentioned that data to support approval of an interchangeable product includes demonstrating biosimilarity, along with additional requirements outlined by statute. These include showing that the product is expected to produce the same clinical result as the reference product in all licensed conditions of us...	sdg	gretel	summary	open-ended	Per dimostrare l'intercambiabilità del biosimilare, la FDA richiede dati che dimostrino la biosimilarità e requisiti aggiuntivi, inclusa la dimostrazione che il prodotto può essere atteso di produrre lo stesso risultato clinico del prodotto di riferimento in tutte le condizioni di utilizzo autorizzate, generalmente sup...	true
2,166	Analise a conexão entre os serviços Janus nonclinical e Kickstart, e informe o número de aplicações carregadas/submetidas em 2019 para ambos?	portuguese	[ "multi-hop", "numerical" ]	instruction	[ "Chart", "Infographic", "Text" ]	[ "From the information available in the PDF, Janus Nonclinical is a database and system that allows reviewers to use SEND datasets for their reviews. Every SEND study received in an application goes through the Janus loading process automatically. Reviewers may request a Kickstart Service to help them with their app...	human	null	image	multi-hop	Janus Nonclinical é um sistema de banco de dados que permite aos revisores usarem conjuntos de dados SEND para suas revisões, e Kickstart é um serviço oferecido pela OCS para auxiliar os revisores com suas aplicações em Janus Nonclinical. Em 2019, 539 aplicações e 1359 estudos foram carregados em Janus Nonclinical.	true
740	Resuma las estrategias clave que implementó la FDA para equilibrar el acceso rápido a tratamientos con la seguridad pública durante la pandemia.	spanish	[ "open-ended" ]	instruction	[ "Image", "Infographic", "Text" ]	[ "The FDA kept in check early treatment access and safety for the public during the pandemic through Emergency Use Authorization (EUA) with a sturdy scientific backup and operative review; fast-tracking trial review through the Coronavirus Treatment Acceleration Program; ongoing and fast dialogue between the FDA and...	sdg	custom_pipeline	summary	open-ended	La FDA equilibró el acceso rápido al tratamiento con la seguridad pública durante la pandemia implementando el proceso de Autorización de Uso de Emergencia (EUA), que proporcionó acceso temprano a terapias cuando los beneficios superaban los riesgos, respaldado por revisión científica. Aceleraron el desarrollo a través...	true
1,594	Welche Entwurfsleitlinie, die im Juni 2018 von der FDA veröffentlicht wurde, bietet Klarheit über die Fälle, in denen ein gemeinsames System zur Risikoevaluierung von Arzneimitteln von Vorteil ist?	german	[ "extractive" ]	question	[ "Image", "Text" ]	[ "The FDA draft guidance published in June 2018, which addresses when a shared system of risk evaluation is beneficial, is called \"Development of a Shared System REMS\"." ]	human	null	summary	extractive	Die FDA-Entwurfsanleitung, die im Juni 2018 veröffentlicht wurde und Klarheit über die Fälle bietet, in denen ein gemeinsames System zur Risikobewertung für Arzneimittel vorteilhaft ist, heißt "Development of a Shared System REMS".	true
902	Enumere los elementos clave del Panel Principal de Exhibición.	spanish	[ "enumerative", "extractive" ]	instruction	[ "Image", "Infographic", "Text" ]	[ "The key elements of the Principal Display Panel are:\n\n1. Proprietary name\n2. Established name or proper name\n3. Product strength\n4. Dosage form\n5. Route of administration\n6. Warnings or cautionary statements." ]	human	null	image	enumerative	Los elementos clave del Panel de Presentación Principal son: Nombre propietario, Nombre establecido o nombre propio, Potencia del producto, Forma posológica, Vía de administración, y Advertencias o declaraciones de precaución.	true
553	Indiquez l'initiative prise pour s'attaquer aux causes profondes des problèmes d'approvisionnement en médicaments et élaborer des solutions à long terme par la FDA en 2018.	french	[ "extractive" ]	instruction	[ "Image", "Text" ]	[ "The FDA announced the FDA Drug Shortage Taskforce in July 2018 to improve understanding of the forces leading to drug shortages and identify potential solutions. The FDA facilitates temporary and long-term strategies to address shortages and distribute information to maintain availability while minimizing risk to ...	human	null	summary	extractive	En juillet 2018, la FDA a annoncé la Taskforce sur les pénuries de médicaments de la FDA pour améliorer la compréhension des forces conduisant aux pénuries de médicaments et identifier des solutions potentielles. La Taskforce a organisé des sessions d'écoute avec les parties prenantes auprès des pharmacies, des hôpitau...	true
877	Resuma los pasos involucrados en la notificación de errores en el MERP de ISMP.	spanish	[ "multi-hop" ]	instruction	[ "Infographic", "Other", "Text" ]	[ "Report received and entered into ISMP database; professional staff review and gather additional information if necessary; report identified for further investigation to share lessons learned; further investigation conducted with additional resources; realistic, measurable, and attainable recommendations identified...	human	null	summary	open-ended	Informe recibido y ingresado en la base de datos ISMP; personal profesional revisa y recopila información adicional si es necesario; informe identificado para investigación adicional para compartir lecciones aprendidas; investigación adicional realizada con recursos adicionales; recomendaciones realistas, medibles y al...	true
78	Explain how the hierarchical pyramid model supports the FDA's biosimilar approval process.	english	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The FDA’s biosimilar approval process requires a 351(k) application with adequate data showing the proposed product is highly similar to the US-licensed reference product, allowing for minor differences in inactive components. Analytical data, being more sensitive than clinical data, forms the foundation for detec...	sdg	custom_pipeline	summary	open-ended	The hierarchical pyramid model supports the FDA's biosimilar approval process by establishing a tiered approach where analytical data forms the foundation, followed by animal studies, clinical pharmacology, and additional clinical studies. This model requires a 351(k) application demonstrating that the proposed product...	true
1,513	FDA-Ansatz zur Bewertung der Sicherheit von Hilfsstoffen durch Brückenjustierungen	german	[ "open-ended" ]	keyword	[ "Image", "Infographic", "Table", "Text" ]	[ "The FDA evaluates excipient safety using bridging justifications when a proposed excipient differs from prior uses, but enough data from similar excipients or contexts exist to reasonably infer safety. When justified, the approach uses a body of information to extrapolate safety in cases where specific data do not...	sdg	gretel	summary	open-ended	Die FDA bewertet die Sicherheit von Hilfsstoffen unter Verwendung von Brückenbegründungen, wenn ein vorgeschlagener Hilfsstoff von vorherigen Anwendungen abweicht, aber ausreichende Daten aus ähnlichen Hilfsstoffen oder Kontexten vorhanden sind, um die Sicherheit vernünftig abzuleiten. Dieser Ansatz verwendet vorhanden...	true
1,666	Naloxon vs. Medikamentöse unterstützte Behandlung (MAT)	german	[ "compare-contrast" ]	keyword	[ "Image", "Table", "Text" ]	[ "The FDA has different approaches to support MAT and Naloxone as a treatment for Opioid Use Disorder. For Naloxone, the FDA has aimed to conduct studies to facilitate the switch from prescription to OTC naloxone, which will increase its excess as an intervention measure. Meanwhile, to promote the development of MAT...	human	null	image	compare-contrast	Die FDA unterstützt Naloxon, indem sie Wege zur Erweiterung des Zugangs und zur Erleichterung des Wechsels von verschreibungspflichtigem auf OTC-Naloxon erforscht, einschließlich einer Etikettierungsstudie. Für die medikamentöse unterstützte Behandlung (MAT) fördert die FDA die Entwicklung neuer Optionen, unterstützt d...	true
705	¿Cómo difieren los riesgos relacionados con la concentración del remdesivir y el Propoven 2% en los desafíos de seguridad de los medicamentos durante la pandemia?	spanish	[ "compare-contrast" ]	question	[ "Image", "Text" ]	[ "During the pandemic, Remdesivir faced a concentration-related risk due to unclear labeling. Its lyophilized powder's dosage is labeled 100 mg, while its injection solution's label reads 5mg/mL. Only below this, it mentions the total contents of the vial in small text, which is 21.2 mL. The demand for Propoven incr...	sdg	custom_pipeline	summary	compare-contrast	Durante la pandemia, el remdesivir enfrentó riesgos relacionados con la concentración debido a la etiquetación poco clara: su polvo liofilizado está etiquetado como 100 mg, mientras que la solución inyectable está etiquetada como 5 mg/mL, con el volumen total de 21,2 mL anotado en texto pequeño, lo que podría conducir ...	true
1,391	Welche spezifischen Workshops und Foren hat die FDA durchgeführt, um Probleme bei der Entwicklung von Generika anzugehen, und worauf lag jeweils der Schwerpunkt?	german	[ "enumerative" ]	question	[ "Image", "Text" ]	[ "-In April 2021, Generic Drug Forum 2021: Lifecycle of a Generic Drug.\n-In June 2021, Generic Drug Regulatory Science Initiatives Public Workshop.\n-In August 2021, IVRT and IVPT Methods: Best practices and scientific considerations for ANDA submission\n-In September 2021, Advancing Generic Drug Development: Trans...	sdg	custom_pipeline	summary	enumerative	Im April 2021 führte die FDA das Generic Drug Forum 2021: Lifecycle of a Generic Drug durch. Im Juni 2021 fand der Public Workshop zu den Generic Drug Regulatory Science Initiatives statt. Im August 2021 fand der Workshop zu den IVRT- und IVPT-Methoden: Best practices and scientific considerations for ANDA submission s...	true
2,004	Distinguir entre a boa prática de fabricação atual e a ICH Q10 nas atividades farmacêuticas.	portuguese	[ "compare-contrast" ]	instruction	[ "Infographic", "Text" ]	[ "Current Good Manufacturing Practice (CGMP) establishes a minimum standard for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, whereas ICH Q10 outlines a pharmaceutical quality system that is applied throughout the product lifecycle to enable innovation and cont...	human	null	image	compare-contrast	A Boa Prática de Fabricação Atual (CGMP) estabelece um padrão mínimo para sistemas que asseguram projeto adequado, monitoramento e controle dos processos e instalações de fabricação, enquanto o ICH Q10 descreve um sistema de qualidade farmacêutico aplicado ao longo do ciclo de vida do produto para facilitar inovação e ...	true
709	¿Qué pasos toma la FDA para garantizar que los productos biosimilares sean seguros y eficaces antes de su aprobación?	spanish	[ "open-ended" ]	question	[ "Infographic", "Text" ]	[ "The steps taken by the FDA to ensure biosimilar products are safe and effective before approval include ensuring that the biosimilar product is highly similar to the reference product approved by PHS and has no clinically meaningful differences, implementing Biologics Price Competition and Innovation Act (BPCI Act...	sdg	gretel	summary	open-ended	La FDA asegura que los productos biosimilares sean seguros y efectivos antes de la aprobación requiriendo que sean altamente similares al producto de referencia sin diferencias clínicamente significativas, implementando la Ley de Competencia y Innovación en Precios de Biológicos (Ley BPCI) que creó una vía de autorizac...	true
145	FDA approach to evaluating excipient safety through bridging justifications	english	[ "open-ended" ]	keyword	[ "Image", "Infographic", "Table", "Text" ]	[ "The FDA evaluates excipient safety using bridging justifications when a proposed excipient differs from prior uses, but enough data from similar excipients or contexts exist to reasonably infer safety. When justified, the approach uses a body of information to extrapolate safety in cases where specific data do not...	sdg	gretel	summary	open-ended	The FDA evaluates excipient safety using bridging justifications when a proposed excipient differs from prior uses, but sufficient data from similar excipients or contexts exist to reasonably infer safety. This approach uses existing nonclinical and clinical data, comparing similarities and differences in properties, r...	true
623	Expliquez comment la Drug Supply Chain Security Act sera mise en œuvre par le Office of Drug Security d'ici 2023 afin de sécuriser la chaîne d'approvisionnement des médicaments.	french	[ "open-ended" ]	instruction	[ "Infographic", "Text" ]	[ "The Drug Supply Chain Security Act aims to develop an electronic, interoperable system by 2023 to secure the drug supply chain. It facilitates the exchange of information by trading partners, improves the efficiency of recalls, enables prompt response to suspect and illegitimate products, and creates transparency ...	human	null	summary	open-ended	Le Bureau de la sécurité des médicaments fera progresser la loi sur la sécurité de la chaîne d'approvisionnement en médicaments en atteignant son objectif de développer un système électronique, interopérable d'ici 2023 pour identifier et tracer les médicaments sur ordonnance au niveau du paquet. Ce système facilitera l...	true
1,031	gestione dei risultati di laboratorio categorici nelle sottomissioni di dati CDISC-SEND	italian	[ "open-ended" ]	keyword	[ "Infographic", "Table", "Text" ]	[ "Management of categorical laboratory results in CDISC-SEND focuses on avoiding misplacement of values in LBSTRESN, since this leads to incorrect numeric summaries instead of simple counts. The FDA found problems such as wrong reporting, no clear flag for categorical data, inconsistent metadata, and poor standardiz...	sdg	gretel	summary	open-ended	La gestione dei risultati di laboratorio categorici nelle sottomissioni di dati CDISC-SEND implica la corretta segnalazione come conteggi, non come sintesi numeriche. Il problema principale è la collocazione errata dei risultati categorici nella variabile LBSTRESN, che porta a una segnalazione errata di medie e deviazi...	true
498	Quels sont les facteurs clés contribuant aux vulnérabilités de la chaîne d'approvisionnement pharmaceutique que la FDA identifie par le biais de la surveillance intégrée des données ?	french	[ "enumerative", "open-ended" ]	question	[ "Chart", "Image", "Infographic", "Text" ]	[ "The key factors contributing to pharmaceutical supply chain vulnerabilities are immature quality management systems and a lack of manufacturing redundancy. The FDA identifies these through integrated data surveillance to predict and prevent drug shortages before they occur." ]	sdg	custom_pipeline	summary	enumerative	Les facteurs clés contribuant aux vulnérabilités de la chaîne d'approvisionnement pharmaceutique que la FDA identifie par le biais de la surveillance intégrée des données sont des systèmes de gestion de la qualité immatures et un manque de redondance de fabrication.	true
1,060	Requisiti DSCSA per la tracciabilità dei farmaci soggetti a prescrizione 2023	italian	[ "extractive" ]	keyword	[ "Chart", "Image", "Text" ]	[ "The DSCSA requirements for prescription drug traceability 2023 assure secure electronic exchange of Transaction Statement and Transaction information that also includes package-level product identifiers. Also, the system must enable verification of products using numerical identifiers." ]	sdg	gretel	summary	extractive	I requisiti della DSCSA per la tracciabilità dei farmaci da prescrizione nel 2023 richiedono lo scambio sicuro, elettronico di informazioni sulle transazioni e dichiarazioni di transazione, inclusi identificatori di prodotto a livello di confezione, e sistemi per la verifica dei prodotti a livello di confezione.	true
203	What are the three types of FDA shrinkage estimates based on the amount of borrowing?	english	[ "enumerative", "extractive" ]	question	[ "Infographic" ]	[ "The three types of FDA shrinkage estimates based on the amount of borrowing are:\nSample Estimate: This corresponds to no borrowing.\nShrinkage Estimate: This corresponds to some borrowing.\nOverall Estimate: This corresponds to 100% borrowing." ]	human	null	image	enumerative	The three types of FDA shrinkage estimates based on the amount of borrowing are: Sample Estimate (no borrowing), Shrinkage Estimate (some borrowing), and Overall Estimate (100% borrowing).	true
5	management of categorical laboratory results in CDISC-SEND data submissions	english	[ "open-ended" ]	keyword	[ "Infographic", "Table", "Text" ]	[ "Management of categorical laboratory results in CDISC-SEND focuses on avoiding misplacement of values in LBSTRESN, since this leads to incorrect numeric summaries instead of simple counts. The FDA found problems such as wrong reporting, no clear flag for categorical data, inconsistent metadata, and poor standardiz...	sdg	gretel	summary	open-ended	Management of categorical laboratory results in CDISC-SEND data submissions involves correctly reporting them as counts, not numeric summaries. The primary issue is the misplacement of categorical results in the LBSTRESN variable, which leads to incorrect reporting of means and standard deviations instead of incidence ...	true
1,662	Unterscheiden Sie zwischen der aktuellen guten Herstellungspraxis und ICH Q10 in pharmazeutischen Tätigkeiten.	german	[ "compare-contrast" ]	instruction	[ "Infographic", "Text" ]	[ "Current Good Manufacturing Practice (CGMP) establishes a minimum standard for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, whereas ICH Q10 outlines a pharmaceutical quality system that is applied throughout the product lifecycle to enable innovation and cont...	human	null	image	compare-contrast	Current Good Manufacturing Practice (CGMP) stellt einen Mindeststandard für Systeme fest, die eine ordnungsgemäße Gestaltung, Überwachung und Steuerung von Herstellungsprozessen und -anlagen sicherstellen, während ICH Q10 ein pharmazeutisches Qualitätssystem beschreibt, das über den gesamten Produktlebenszyklus hinweg ...	true
338	Number of CDER approved NMEs without priority review.	english	[ "extractive", "numerical" ]	keyword	[ "Infographic", "Table", "Text" ]	[ "45 NMEs approved in FY 2019.\n32 Priority Reviewed NMEs.\nSo, without priority review = 45 − 32 = 13.", "CDER approved 13 NMEs (FY2020), of which 7 had priority review, leaving 6 without priority.\nCDER approved 45 NMEs (FY2019), of which 32 had priority review, leaving 13 without priority. So adding them togeth...	human	null	summary	numerical	45 NMEs were approved in FY 2019, of which 32 had priority review, leaving 13 without priority review.	true

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