Recently Issued Guidance Documents
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Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry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Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry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 -
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; 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Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff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Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry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Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry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Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry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Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry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 -
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