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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
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Guidance Snapshot Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Podcast Clinical Pharmacology Considerations for Antibody-Drug Conjugates: Podcast Transcript Final 03/01/2024
Master Protocols for Drug and Biological Product Development Master Protocols: Guidance Snapshot Master Protocols: Podcast Master Protocols: Transcript Draft 12/22/2023
Drug-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 6/22/2023
Translation 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 11/21/2023
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 Final 10/20/2023
Adjusting 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 5/26/2023
Use 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 5/25/2023
Enhancing 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 11/13/2020
Enhancing 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 11/13/2020
Evaluation 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 3/10/2023
Considerations 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 2/10/2023
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
Product-Specific Guidances for Generic Drug Development Product-Specific Guidance Snapshot     Multiple Multiple
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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