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 In this section:

                Guidances | Drugs

Guidances | Drugs

                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Guidances | Drugs
          Guidance Snapshot PilotGuidances | Drugs Guidance Snapshot Pilot
  
  	
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    PrintGuidance Snapshots at a glance

FDA guidance documents contain the Agency’s current best thinking on a particular topic. To support transparent communication and dissemination of FDA guidance documents, FDA is launching the Guidance Snapshot Pilot for a subset of cross-cutting guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language. This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents’ recommendations.

How to read Guidance Snapshots
	Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance documents. During the Pilot, Guidance Snapshots will contain a subset of the following key features:

Explanation of why the guidance document is important
	Highlights from the guidance document
	Educational background about the guidance topic
	Link to the full guidance document
	Drug development timeline for when to apply the guidance recommendations
	Guidance Recap Podcast that describes highlights and background the guidance document explained directly from the authors
	Twitter hashtags to create a platform for discussing views on the guidance
	Link to the FDA docket for providing official comments to the Agency (for applicable draft guidances)

Limitations of Guidance Snapshots
	Guidance Snapshots are a communication tool intended to increase general public awareness and engagement for FDA guidance documents. Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.

Guidance Snapshots


Guidance Document
			Guidance Snapshot
			Guidance Recap Podcast
			Podcast Transcript
			Guidance Type
			Guidance Issue DateMaster Protocols for Drug and Biological Product Development
			Master Protocols: Guidance Snapshot
			Master Protocols: Podcast
			Master Protocols: Transcript
			Draft
			12/22/2023Drug-Drug Interaction Assessment for Therapeutic Proteins
			Drug-Drug Interaction Assessment for Therapeutic Proteins - Guidance Snapshot
			Drug-Drug Interaction Assessment for Therapeutic Proteins: Podcast
			Drug-Drug Interaction Assessment for Therapeutic Proteins: Podcast Transcript
			Final
			6/22/2023Translation of Good Laboratory Practice Study Reports: Questions and Answers
			Translation of Good Laboratory Practice Study Reports: Guidance Snapshot
			Translation of Good Laboratory Practice Study Reports: Podcast
			Translation of Good Laboratory Practice Study Reports: Podcast Transcript
			Draft
			11/21/2023Benefit-Risk Assessment for New Drug and Biologic Products
			Benefit-Risk Assessment for New Drug and Biologic Products Snapshot
			Benefit-Risk Assessment for New Drug and Biologic Products Podcast
			Benefit-Risk Assessment for New Drug and Biologic Products Transcript
			Final
			10/20/2023Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
			Adjusting Covariates -
			Guidance Snapshot
			Adjusting Covariates -
			Guidance Recap Podcast
			Adjusting Covariates -
			Guidance Recap Podcast Transcript
			Final
			5/26/2023Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
			Whole Slide Imaging -Guidance Snapshot
			Whole Slide Imaging -Guidance Recap Podcast
			Whole Slide Imaging -Guidance Recap Podcast Transcript
			Final
			5/25/2023Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
			Enhancing the Diversity of Clinical Trial Populations - Guidance Snapshot
			Enhancing the Diversity of Clinical Trial Populations - Guidance Recap Podcast
			Enhancing the Diversity of Clinical Trial Populations - Guidance Recap Podcast Transcript
			Final
			11/13/2020Enhancing the Diversity of Clinical Trial Populations - Guidance Snapshot for Patients
			Enhancing the Diversity of Clinical Trial Populations - Guidance Recap Podcast for Patients
			Enhancing the Diversity of Clinical Trial Populations - Guidance Recap Podcast Transcript for Patients
			Final
			11/13/2020Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
			Evaluation of Gastric pH Dependent DDIs -Guidance Snapshot
			Evaluation of Gastric pH Dependent DDIs -Guidance Recap Podcast
			Evaluation of Gastric pH Dependent DDIs -Guidance Recap Podcast Transcript
			Final
			3/10/2023Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
			Neonatal Neurodevelopmental Safety Studies Guidance Snapshot
			Neonatal Neurodevelopmental Safety Studies Guidance Recap Podcast
			Neonatal Neurodevelopmental Safety Studies Guidance Recap Podcast Transcript
			Draft
			2/10/2023Multiple Endpoints in Clinical Trials
			Multiple Endpoints Guidance Snapshot
			Multiple Endpoints Guidance Recap Podcast
			Multiple Endpoints Guidance Recap Podcast Transcript
			Final
			10/21/2022Ethical Considerations for Clinical Investigations of Medical Products Involving Children
			Ethical Considerations for Clinical Investigations Involving Children -Guidance Snapshot
			Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast
			Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast Transcript
			Draft
			9/26/2022General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
			Neonatal Guidance Snapshot
			Neonatal Guidance Recap Podcast
			Neonatal Guidance Recap Podcast Transcript
			Final
			7/27/2022Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
			PFDD COA
			Guidance
			Snapshot
			PFDD COA
			Guidance Recap
			Podcast
			PFDD COA
			Guidance Recap
			Podcast Transcript
			Draft
			6/30/2022Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations
			Food Effects Guidance Snapshot
			Food Effects Guidance Recap Podcast
			Food Effects Guidance Recap Podcast Transcript
			Final
			6/24/2022Bioavailability Studies Submitted in NDAs or INDs – General Considerations
			Bioavailability Guidance Snapshot
			Bioavailability Guidance Recap Podcast
			Bioavailability Guidance Recap Podcast Transcript
			Final
			4/15/2022Population Pharmacokinetics
			Population Pharmacokinetics Guidance Snapshot
			Population Pharmacokinetics Guidance Recap Podcast
			Population Pharmacokinetics Guidance Recap Podcast Transcript
			Final
			2/3/2022Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
			Pathology Peer Review Guidance Snapshot
			Pathology Peer Review Guidance Recap Podcast
			Pathology Peer Review Guidance Recap Podcast Transcript
			Final
			12/27/2021Product-Specific Guidances for Generic Drug Development
			Product-Specific Guidance Snapshot
			
			
			Multiple
			MultipleIn Vitro Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance
			In Vitro DDI Guidance Snapshot
			In Vitro DDI Guidance Recap Podcast
			In Vitro DDI Guidance Recap Podcast Transcript
			Final
			01/23/2020Clinical Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance
			Clinical DDI Guidance Snapshot
			Clinical DDI Guidance Recap Podcast
			Clinical DDI Guidance Recap Podcast Transcript
			Final
			01/23/2020Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
			CID Snapshot
			CID Guidance Recap Podcast
			CID Guidance Recap Podcast Transcript
			Final
			12/16/2020Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations Final Guidance
			MUsT Snapshot
			
			
			Final
			05/10/2019Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final Guidance
			Targeted Therapies Guidance Snapshot
			
			
			Final
			10/16/2018

                                                                                  Content current as of:
      12/21/2023
              
              
Regulated Product(s)
		 DrugsGuidances | Drugs

          
                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot
 
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