Recently Issued Guidance Documents
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Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry
CDER/CBER, September 2023 -
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry
CDER/CBER, September 2023 -
Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for IRBs and Clinical Investigators
CDER/CBER/OCE, September 2023 -
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff
OCP/CDRH/CDER/CBER, September 2023 -
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry
CDER/CBER/ORA, September 2023 -
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, August 2023 -
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
CDER/CBER/ORA, September 2023 -
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry
CDER/CBER/ORA, August 2023 -
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry
CDER/CBER/ORA, August 2023 -
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
OCP/CDER/CBER/CDRH, August 2023 -
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
OCE/CDER/CBER, August 2023 -
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
For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Andrew Byrnes, Gene Transfer & Immunogenicity Branch Chief, Office of Gene Therapy CMC, Office of Therapeutic Products, CBER. -
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