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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 DocumentGuidance SnapshotGuidance Recap PodcastPodcast TranscriptGuidance TypeGuidance Issue Date
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product DevelopmentNeonatal Neurodevelopmental Safety Studies Guidance SnapshotNeonatal Neurodevelopmental Safety Studies Guidance Recap PodcastNeonatal Neurodevelopmental Safety Studies Guidance Recap Podcast TranscriptFinal10/18/2024
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesClinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Guidance SnapshotClinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: PodcastClinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Podcast TranscriptFinal07/18/2024
Medication Guide: Patient Medication
Information (PMI) Proposed Rule
Patient Medication
Information (PMI): Proposed Rule Snapshot
Patient Medication
Information (PMI): Podcast
Patient Medication
Information (PMI): Podcast Transcript
Proposed Rule5/31/2023
Patient Medication
Information (PMI): Proposed Rule Snapshot for Patients
Patient Medication
Information (PMI): Podcast for Patients
Patient Medication
Information (PMI): Podcast Transcript for Patients
Proposed Rule5/31/2023
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance DocumentDigital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance SnapshotDigital Health Technologies for Remote Data Acquisition in Clinical Investigations: PodcastDigital Health Technologies for Remote Data Acquisition in Clinical Investigations: Podcast TranscriptFinal12/22/2023
Clinical Pharmacology Considerations for the Development of Oligonucleotide TherapeuticsClinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance SnapshotClinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: PodcastClinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Podcast TranscriptFinal06/14/2024
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical TrialsE19 A Selective Approach to Safety Data Collection: Guidance SnapshotE19 A Selective Approach to Safety Data Collection: PodcastE19 A Selective Approach to Safety Data Collection: Podcast TranscriptFinal12/05/2022
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on DosingPharmacokinetics in Patients with Impaired Renal Function: Guidance SnapshotPharmacokinetics in Patients with Impaired Renal Function: PodcastPharmacokinetics in Patients with Impaired Renal Function: Podcast TranscriptFinal3/18/2024
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for IndustryClinical Pharmacology Considerations for Antibody-Drug Conjugates: Guidance SnapshotClinical Pharmacology Considerations for Antibody-Drug Conjugates: PodcastClinical Pharmacology Considerations for Antibody-Drug Conjugates: Podcast TranscriptFinal03/01/2024
Master Protocols for Drug and Biological Product DevelopmentMaster Protocols: Guidance SnapshotMaster Protocols: PodcastMaster Protocols: TranscriptDraft12/22/2023
Drug-Drug Interaction Assessment for Therapeutic ProteinsDrug-Drug Interaction Assessment for Therapeutic Proteins - Guidance Snapshot Drug-Drug Interaction Assessment for Therapeutic Proteins: PodcastDrug-Drug Interaction Assessment for Therapeutic Proteins: Podcast TranscriptFinal6/22/2023
Translation of Good Laboratory Practice Study Reports: Questions and AnswersTranslation of Good Laboratory Practice Study Reports: Guidance SnapshotTranslation of Good Laboratory Practice Study Reports: PodcastTranslation of Good Laboratory Practice Study Reports: Podcast TranscriptDraft11/21/2023
Benefit-Risk Assessment for New Drug and Biologic ProductsBenefit-Risk Assessment for New Drug and Biologic Products SnapshotBenefit-Risk Assessment for New Drug and Biologic Products PodcastBenefit-Risk Assessment for New Drug and Biologic Products TranscriptFinal10/20/2023
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological ProductsAdjusting Covariates -
Guidance Snapshot
Adjusting Covariates -
Guidance Recap Podcast
Adjusting Covariates -
Guidance Recap Podcast Transcript
Final5/26/2023
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and AnswersWhole Slide Imaging -Guidance SnapshotWhole Slide Imaging -Guidance Recap PodcastWhole Slide Imaging -Guidance Recap Podcast TranscriptFinal5/25/2023
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical ImplicationsEvaluation of Gastric pH Dependent DDIs -Guidance SnapshotEvaluation of Gastric pH Dependent DDIs -Guidance Recap PodcastEvaluation of Gastric pH Dependent DDIs -Guidance Recap Podcast TranscriptFinal3/10/2023
Multiple Endpoints in Clinical TrialsMultiple Endpoints Guidance SnapshotMultiple Endpoints Guidance Recap PodcastMultiple Endpoints Guidance Recap Podcast TranscriptFinal10/21/2022
Ethical Considerations for Clinical Investigations of Medical Products Involving ChildrenEthical Considerations for Clinical Investigations Involving Children -Guidance SnapshotEthical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast TranscriptDraft9/26/2022
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological ProductsNeonatal Guidance SnapshotNeonatal Guidance Recap PodcastNeonatal Guidance Recap Podcast TranscriptFinal7/27/2022
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsPFDD COA
Guidance
Snapshot
PFDD COA
Guidance Recap
Podcast
PFDD COA
Guidance Recap
Podcast Transcript
Draft6/30/2022
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology ConsiderationsFood Effects Guidance SnapshotFood Effects Guidance Recap PodcastFood Effects Guidance Recap Podcast TranscriptFinal6/24/2022
Bioavailability Studies Submitted in NDAs or INDs – General ConsiderationsBioavailability Guidance SnapshotBioavailability Guidance Recap PodcastBioavailability Guidance Recap Podcast TranscriptFinal4/15/2022
Population PharmacokineticsPopulation Pharmacokinetics Guidance SnapshotPopulation Pharmacokinetics Guidance Recap PodcastPopulation Pharmacokinetics Guidance Recap Podcast TranscriptFinal2/3/2022
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and AnswersPathology Peer Review Guidance SnapshotPathology Peer Review Guidance Recap PodcastPathology Peer Review Guidance Recap Podcast TranscriptFinal12/27/2021
Product-Specific Guidances for Generic Drug DevelopmentProduct-Specific Guidance Snapshot  MultipleMultiple
In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final GuidanceIn Vitro DDI Guidance SnapshotIn Vitro DDI Guidance Recap PodcastIn Vitro DDI Guidance Recap Podcast TranscriptFinal01/23/2020
Clinical Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final GuidanceClinical DDI Guidance SnapshotClinical DDI Guidance Recap PodcastClinical DDI Guidance Recap Podcast TranscriptFinal01/23/2020
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological ProductsCID SnapshotCID Guidance Recap PodcastCID Guidance Recap Podcast TranscriptFinal12/16/2020
Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations Final GuidanceMUsT Snapshot  Final05/10/2019
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final GuidanceTargeted Therapies Guidance Snapshot  Final10/16/2018
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