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  1. Guidances | Drugs

Guidance Snapshot Pilot

Guidance 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.


Guidance Snapshots

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Guidance Document Guidance Snapshot Guidance Recap Podcast Podcast Transcript Guidance Type Guidance Issue Date
Multiple Endpoints in Clinical Trials Multiple Endpoints Guidance Snapshot Multiple Endpoints Guidance Recap Podcast Multiple Endpoints Guidance Recap Podcast Transcript Final 10/21/2022
Ethical 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 9/26/2022
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Neonatal Guidance Snapshot Neonatal Guidance Recap Podcast Neonatal Guidance Recap Podcast Transcript Final 7/27/2022
Patient-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 6/30/2022
Assessing 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 6/24/2022
Bioavailability Studies Submitted in NDAs or INDs – General Considerations Bioavailability Guidance Snapshot Bioavailability Guidance Recap Podcast Bioavailability Guidance Recap Podcast Transcript Final 4/15/2022
Population Pharmacokinetics Population Pharmacokinetics Guidance Snapshot Population Pharmacokinetics Guidance Recap Podcast Population Pharmacokinetics Guidance Recap Podcast Transcript Final 2/3/2022
Pathology 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 12/27/2021
Benefit-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 Draft 09/30/2021
Product-Specific Guidances for Generic Drug Development Product-Specific Guidance Snapshot     Multiple Multiple
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Adjusting for Covariates Guidance Snapshot Adjusting for Covariates Guidance Recap Podcast Adjusting for Covariates Guidance Recap Podcast Transcript Draft 05/20/2021
In 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 01/23/2020
Clinical 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 01/23/2020
Interacting 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 12/16/2020
Maximal 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 05/10/2019
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final Guidance Targeted Therapies Guidance Snapshot     Final 10/16/2018
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