Recently Issued Guidance Documents
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Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, March 2024 -
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024 -
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2024 -
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, March 2024 -
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry
CDER/CBER, March 2024 -
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OCLiP/OHRP, March 2024 -
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
CDER/CBER/CVM, February 2024 -
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry
CDER/CBER, February 2024 -
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, February 2024 -
Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry
CDER/CBER/OCE, February 2024 -
Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry
CDER/CBER/CDRH, February 2024 -
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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry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Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry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Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry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