Recently Issued Guidance Documents
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Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Guidance for Industry
CDER/CBER/CVM, February 2024 -
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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry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, February 2024 -
Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry
ORA/OFPR/OCP/CBER/CDER/CDRH/OC/OCE/CFSAN/CTP/CVM, February 2024 -
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry
CDER/CBER/CDRH/OC/OCE/OMHHE/OWH/OCLiP/OPT, January 2024 -
Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry
CBER, January 2024 -
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry
CBER, January 2024 -
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2024 -
Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry
CBER, December 2023 -
Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry
CDER/CBER, December 2023 -
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
CDER/CBER, December 2023 -
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, December 2023 -
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders
CDER/CBER/CDRH/OCE, December 2023 -
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry
CDER/CBER, December 2023 -
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
CDRH/CBER, December 2023 -
Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry
CDER/CBER, December 2023 -
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry
CDER/CBER/ORA, December 2023 -
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
CBER, October 2023 (Updated November 27, 2023) -
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
CDER/CBER, November 2023 -
Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/CFSAN/CTP/ORA, November 2023 -
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, November 2023 -
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, November 2023 -
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry
CDER/CBER/CVM, October 2023 -
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/OC, October 2023 -
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
CBER, October 2023 -
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry
CDER/CBER/CVM, October 2023 -
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry
CBER, October 2023 -
Investigational COVID-19 Convalescent Plasma; Guidance for Industry
CBER, October 2023 (Updated October 13, 2023) -
Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, October 2023 -
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”; Guidance for Industry
CDER/CBER, October 2023 -
Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2023 -
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry
OCE/CDER/CBER/CDRH, September 2023 -
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
CDER/CBER, September 2023 -
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry
CDER/CBER, September 2023 -
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OCE/OCLiP, September 2023 -
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry
CDER/CBER, September 2023 -
Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry
CDER/CBER/CDRH/OCE/OCP, September 2023 -
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry
CDER/CBER/OCE, September 2023 -
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