Recently Issued Guidance Documents
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.
-
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry
CBER, March 2022 -
Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry
CBER, March 2022 -
Inclusion of Older Adults in Cancer Clinical Trials
CDER/CBER/OCE, March 2022 -
Expansion Cohorts: Use in First-in-Human Clinical Trials; Guidance for Industry
CDER/CBER, March 2022 -
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry
CDER/CBER/OCE, March 2022 -
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER, February 2022 -
Population Pharmacokinetics; Guidance for Industry
CDER/CBER, February 2022 -
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry
CDER/CBER, February 2022 -
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format; Draft Guidance for Industry
CDER/CBER, February 2022 -
Investigational COVID-19 Convalescent Plasma; Guidance for Industry
(Updated January 7, 2022) CBER, January 2022 -
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations - Guidance for Industry, Investigators, and Other Stakeholders; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, December 2021 -
Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry
CDER/CBER/CVM, December 2021 -
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency; Guidance for Industry and Health Professionals
CBER, December 2021 -
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, December 2021 - Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry
CDER/CBER, December 2021 -
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, December 2021 -
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry
CDER/CBER, December 2021 -
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry; Draft Guidance for Industry
CDER/CBER/OCE, November 2021 -
Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry
CBER, November 2021 -
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
CDER/CBER, October 2021 -
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry
CDER/CBER/CVM, October 2021 -
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry
CDER/CBER, October 2021