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                Pediatrics

Pediatrics

                        FDA Perspectives on Pediatric Health
          Pediatric Medical Product Safety
          Pediatric Ethics
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          Pediatrics
          FDA Perspectives on Pediatric HealthPediatrics FDA Perspectives on Pediatric Health
  
  					FDA’s Pediatric Activities and Perspectives Shared with Clinicians through the American Academy of Pediatrics News
	
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    PrintFDA publishes a monthly column in *AAP News*, the monthly news magazine of the American Academy of Pediatrics (AAP) to provide insights from FDA experts. The column, *FDA Updates*, covers issues related to pediatric health such as new pediatric medical products approved by the FDA, important pediatric safety warnings, information about the agency’s pediatric initiatives and progress in pediatric product development. See the searchable table below for FDA’s articles featured in *AAP News*.

See page archive for articles before 2016.

Filter Table by Topic Addiction/Substance Use DisorderAdolescent HealthAllergy/ImmunologyCardiologyClinical Trials/Product DevelopmentCosmeticsDermatologyEndocrine/MetabolicEthicsGastroenterologyGeneral InformationGeneral PediatricsGeneric Drugs/BiosimilarsHealth EquityHematologyInfectious DiseaseMaternal HealthMedical CountermeasuresMedical ImagingNeonatologyNephrologyNeurologyNew Drug/Biologic Approval/Label ChangeNutritionOncologyOtolaryngologyOver-the-Counter MedicinesPediatric DevicePediatric InitiativePharmacovigilancePreventive VaccinePsychiatryPulmonologyRare DiseaseRheumatologySafety WarningTobacco PreventionUrology

Clear Filters

Month/Year
			Title
			Topic11/2023
			Law expands FDA’s authority to regulate cosmetics
			Cosmetics10/2023
			FDA explains safety reporting for new RSV monoclonal antibody
			Infectious Disease; Pharmacovigilance09/2023
			First treatment for pediatric functional constipation approved by FDA
			New Drug/Biologic Approval/Label Change; Gastroenterology08/2023
			FDA advises educating families on availability, use of nonprescription naloxone
			Addiction/Substance Use Disorder07/2023
			Reassured by adult safety study, FDA approves sildenafil for children
			New Drug/Biologic Approval/Label Change; Cardiology06/2023
			FDA prioritizes neurodevelopmental safety of medical products used in neonates
			Clinical Trials/Product Development; Neonatology; General Pediatrics05/2023
			FDA adapts efforts to address evolving tobacco product landscape
			Pediatric Initiative; Tobacco Prevention; Adolescent Health04/2023
			Pediatric information added to labeling of 75 drugs, biologics in 2022
			New Drug/Biologic Approval/Label Change03/2023
			Drug development for pediatric cancers accelerating
			Clinical Trials/Product Development; Oncology02/2023
			FDA provides guidance on assessing growth, pubertal development in pediatric clinical trials
			Clinical Trials/Product Development; General Pediatrics; Endocrine/Metabolic01/2023
			FDA approves first drug that can delay onset of type 1 diabetes
			New Drug/Biologic Approval/Label Change; Endocrine/Metabolic12/2022
			FDA outlines ethical framework for including children in clinical trials
			Clinical Trials/Product Development; Ethics11/2022
			Extrapolating data can accelerate drug development for children
			Clinical Trials/Product Development10/2022
			‘First generic’ drug approvals provide more affordable options for safe, effective treatments
			Generic Drugs/Biosimilars09/2022
			Historic milestone: 1,000 drugs, biologics have new pediatric use information in labeling
			New Drug/Biologic Approval/Label Change08/2022
			FDA approves Dupixent for eosinophilic esophagitis; expands indication for atopic dermatitis
			New Drug/Biologic Approval/Label Change; Gastroenterology; Allergy/Immunology; Dermatology07/2022
			Risk of pseudotumor cerebri added to labeling for gonadotropin-releasing hormone agonists
			Safety Warning; Endocrine/Metabolic06/2022
			Pediatric committee advises FDA on medical product research, labeling, adverse events
			Clinical Trials/Product Development; Pharmacovigilance04/2022
			FDA: Monitor thyroid in newborns, young children who receive iodine-containing contrast media
			Safety Warning; Medical Imaging; Endocrine/Metabolic04/2022
			New pediatric labeling information added to 73 products in 2021
			New Drug/Biologic Approval/Label Change03/2022
			Closer to Zero: FDA’s action plan to lower toxic elements in baby foods
			Pediatric Initiative; Nutrition02/2022
			FDA provides resources to address youth e-cigarette use
			Pediatric Initiative; Tobacco Prevention; Adolescent Health01/2022
			Biosimilars, interchangeable biological products provide safe, effective treatment options
			Generic Drugs/Biosimilars12/2021
			Transgender teens share perspectives on health care needs during listening session
			Adolescent Health; Health Equity11/2021
			First oral pan-genotypic HCV drugs approved for children as young as 3 years
			New Drug/Biologic Approval/Label Change; Infectious Disease10/2021
			Studies show sitagliptin does not improve glycemic control in pediatric patients
			New Drug/Biologic Approval/Label Change; Endocrine/Metabolic09/2021
			FDA authorizes marketing of tool to aid in diagnosis of autism spectrum
			disorder
			Pediatric Device; Psychiatry08/2021
			FDA approves first oral anticoagulant for pediatric patients
			New Drug/Biologic Approval/Label Change; Hematology07/2021
			New labeling for TMP-SMX products warns of acute respiratory failure
			Safety Warning; Infectious Disease06/2021
			FDA encourages culture change for clinical trial enrollment of pregnant and lactating women
			Clinical Trials/Product Development; Maternal Health05/2021
			FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication
			New Drug/Biologic Approval/Label Change; Oncology; Infectious Disease; Preventive Vaccine04/2021
			2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process
			Clinical Trials/Product Development; Psychiatry03/2021
			FDA committed to advancing minority health
			Health Equity02/2021
			EUAs address medical device needs in pediatric patients during the pandemic
			Pediatric Device; Infectious Disease01/2021
			First FDA-approved treatment for COVID-19 includes use in adolescents
			New Drug/Biologic Approval/Label Change; Infectious Disease; Preventive Vaccine12/2020
			FDA approvals in 2020 represent many firsts for children
			New Drug/Biologic Approval/Label Change11/2020
			FDA engages patient communities through listening session initiative
			Pediatric Initiative10/2020
			Pediatric information added to labeling for 80 drugs, vaccines, blood products
			New Drug/Biologic Approval/Label Change09/2020
			FDA addresses drug shortages during COVID-19 pandemic
			Infectious Disease08/2020
			FDA partners with global agencies on development of COVID-19 therapeutics for children
			Pediatric Initiative; Infectious Disease07/2020
			FDA considers parent preferences, children’s experience in approving novel myringotomy, tube placement device
			Pediatric Device; Otolaryngology06/2020
			FDA highlights imperative to obtain evidence through pediatric clinical trials
			Clinical Trials/Product Development05/2020
			How FDA is responding to COVID-19 pandemic
			Infectious Disease04/2020
			Drug labels include information on use in pediatric patients
			Clinical Trials/Product Development03/2020
			Dr. Sachs retires from FDA, leaving mark on pediatric drug development
			Clinical Trials/Product Development02/2020
			What criteria must drugs meet to be sold over the counter?
			Over-the-Counter Medicines01/2020
			FDA approves first drug for pediatric patients with systemic lupus erythematosus
			New Drug/Biologic Approval/Label Change; Rheumatology12/2019
			Update on success of law that encourages studies of off-patent drugs in children
			Pediatric Initiative11/2019
			Health professionals, patients urged to report adverse events
			Pharmacovigilance10/2019
			FDA campaign promotes safe disposal of opioid pain medicine
			Pediatric Initiative; Addiction/Substance Use Disorder09/2019
			FDA approves 2 products to treat diabetes in pediatric patients
			New Drug/Biologic Approval/Label Change; Endocrine/Metabolic08/2019
			Pediatric safety labeling updated for iron chelation drug
			New Drug/Biologic Approval/Label Change; Hematology; Nephrology; Pharmacovigilance07/2019
			New FDA guidance documents inform pediatric labeling, study conduct
			Clinical Trials/Product Development06/2019
			Adult drug effective for pediatric patients with dilated cardiomyopathy
			New Drug/Biologic Approval/Label Change; Cardiology05/2019
			Pediatric information added to labels of 48 products in 2018
			New Drug/Biologic Approval/Label Change04/2019
			Forum encourages dialogue on Rare Disease programs
			Clinical Trials/Product Development; Rare Disease02/2019
			FDA working to reduce exposure to toxic elements in foods, other products
			Pediatric Initiative; Nutrition01/2019
			FDA warns public about genetic test claims
			Safety Warning12/2018
			FDA explores therapeutic goals in achondroplasia
			Clinical Trials/Product Development; Rare Disease11/2018
			FDA meetings address Pediatric Device development, drug safety
			Pediatric Device; Pharmacovigilance10/2018
			FDA OKs first injectable fish oil triglyceride emulsion for parenteral nutrition
			New Drug/Biologic Approval/Label Change; Nutrition09/2018
			Extrapolation of adult efficacy data leads to pediatric indications for 4 seizure drugs
			New Drug/Biologic Approval/Label Change; Neurology08/2018
			FDA publishes first patient-focused drug development guidance
			Clinical Trials/Product Development07/2018
			HIV PrEP drug can be part of strategy to prevent infection in at-risk adolescents
			New Drug/Biologic Approval/Label Change; Infectious Disease; Adolescent Health07/2018
			First drug to treat relapsing MS in pediatric patients approved
			New Drug/Biologic Approval/Label Change; Neurology06/2018
			New approach to developing cystic fibrosis treatments have wider applications
			Clinical Trials/Product Development; Rare Disease; Pulmonology05/2018
			New pediatric labeling information for 53 products
			New Drug/Biologic Approval/Label Change04/2018
			Consortium, networks dedicated to improving treatments for neonates
			Pediatric Initiative; Neonatology03/2018
			Workshops focus on long-term medication safety, pediatric ‘big data’
			Clinical Trials/Product Development; Pharmacovigilance02/2018
			FDA approves epinephrine auto-injector for infants, toddlers
			New Drug/Biologic Approval/Label Change; Allergy/Immunology01/2018
			FDA working to advance development of drugs for pediatric heart failure
			Clinical Trials/Product Development; Cardiology12/2017
			FDA allows qualified health claim on benefits of early peanut introduction
			Nutrition; Allergy/Immunology11/2017
			FDA committed to affordable generic drugs for children
			Generic Drugs/Biosimilars10/2017
			FDA OKs imaging tool for evaluating VUR without radiation exposure
			New Drug/Biologic Approval/Label Change; Medical Imaging; Urology09/2017
			FDA clears first MRI device for neonates
			Pediatric Device; Medical Imaging; Neonatology08/2017
			FDA reviews ethical question in muscular dystrophy clinical trial
			Clinical Trials/Product Development; Ethics; Rare Disease07/2017
			FDA approves TNF inhibitor to treat children with chronic plaque psoriasis
			New Drug/Biologic Approval/Label Change; Rheumatology06/2017
			New pediatric labeling information available for 52 products
			New Drug/Biologic Approval/Label Change05/2017
			Newborn screening test for lysosomal storage disorders can be marketed
			Pediatric Device; Rare Disease; Neonatology04/2017
			FDA fosters development of therapies for children with Rare Diseases
			Pediatric Initiative; Rare Disease03/2017
			FDA issues new rule on pediatric medical cribs, medical bassinets
			Pediatric Device02/2017
			FDA releases guidance on extrapolating data to enhance Pediatric Device development
			Clinical Trials/Product Development01/2017
			Topical retinoid acne treatment approved for OTC use
			New Drug/Biologic Approval/Label Change; Dermatology; Adolescent Health12/2016
			FDA regulations for e-cigarettes, other tobacco products take effect
			Pediatric Initiative; Tobacco Prevention; Adolescent Health11/2016
			Pediatric Medical Countermeasures approved under Animal Rule
			New Drug/Biologic Approval/Label Change; Medical Countermeasures10/2016
			Workshop participants call for more studies of medication safety during lactation
			Clinical Trials/Product Development; Pharmacovigilance; Maternal Health09/2016
			FDA report highlights successes, challenges in pediatric drug research
			Clinical Trials/Product Development08/2016
			FDA Approves drug to treat active Crohn's disease in pediatric patients
			New Drug/Biologic Approval/Label Change; Gastroenterology07/2016
			New ADHD medications target patients who have trouble swallowing pills
			New Drug/Biologic Approval/Label Change; Psychiatry06/2016
			Patients on perampanel should be monitored for behavior changes
			Safety Warning; Neurology05/2016
			Anti-epileptic drug efficacy in adults can be extrapolated to pediatric patients
			Clinical Trials/Product Development; Neurology04/2016
			New pediatric information available for 52 products
			New Drug/Biologic Approval/Label Change03/2016
			FDA approves first drug to treat rare enzyme disorder in infants, children
			New Drug/Biologic Approval/Label Change; Rare Disease02/2016
			New regimen helps prevent nausea, vomiting in children receiving chemotherapy
			New Drug/Biologic Approval/Label Change; Oncology

                                                                                  Content current as of:
      12/19/2023Pediatrics

          
                        FDA Perspectives on Pediatric Health
          Pediatric Medical Product Safety
          Pediatric Ethics
          International Collaboration / Pediatric Cluster
          Pediatric Science and Research Activities
          Medical Products for Newborns
          Pediatric Labeling Changes
          Reports, Statistics, Reviews and Databases
 
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