Recently Issued Guidance Documents
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Classification Categories for Certain Supplements Under BsUFA III; Draft Guidance for Industry
CDER/CBER, August 2023 -
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
CDER/CBER, August 2023 -
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry
CDER/CBER, August 2023 -
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry
CBER, July 2023 -
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
CDER/CBER, July 2023 -
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry
CDER/CBER, July 2023 -
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry
CDER/CBER, June 2023 -
Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER/OCP, June 2023 -
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements; Guidance for Industry
CDER/CBER/CVM, June 2023 -
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2023 -
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes; Guidance for Industry
CDER/CBER/OCE, May 2023 -
Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry
CDER/CBER, June 2023 -
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, May 2023 -
Study Data Technical Conformance Guide - Technical Specifications Document; Guidance for Industry
CDER/CBER, May 2023 -
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry
CDER/CBER, May 2023 -
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry
CDER/CBER, May 2023 - Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders
CDER/CBER/CDRH/OCE, May 2023 -
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/OCLiP/ORA, April 2023 -
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER/CDRH, April 2023 -
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER/OCP, April 2023 -
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry
CDER/CBER, April 2023