Recently Issued Guidance Documents
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Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry
CDER/CBER, October 2021 -
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry
CBER/OOPD, September 2021 -
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry
CBER, September 2021 -
Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, September 2021 -
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry
CDER/CBER/CDRH, September 2021 -
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, September 2021 -
Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry
CDER/CBER, September 2021 -
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3); Draft Guidance for Industry
CDER/CBER, September 2021 -
ICH Q12: Implementation Considerations for FDA-Regulated Products; Draft Guidance for Industry
CDER/CBER/CDRH, September 2021 -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OC, August 2021 -
Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Guidance for Industry
(Updated August 20, 2021) CBER, August 2021 -
FDA Export Certification; Guidance for Industry
CDER/CBER/CDRH/CFSAN/CVM, August 2021 -
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Guidance for Industry
CDER/CBER, August 2021 -
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER July 2021 -
Field Alert Report Submission: Questions and Answers; Guidance for Industry
CDER/CBER, July 2021 -
Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry
CDER/CBER, July 2021 -
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry
OCE/CDER/CBER, July 2021 -
Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry
CDER/CBER, June 2021 -
Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Industry
OCE/CDER/CBER, June 2021 -
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment; Guidance for Industry
OCE/CDER/CBER, June 2021 -
Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry
CDER/CBER, June 2021 -
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry
CBER/CDER, June 2021 -
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2021 -
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry
CDER/CBER, June 2021 -
Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act; Draft Guidance for Industry
CDER/CBER, June 2021 -
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry
CDER/CBER, June 2021 -
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
CDER/CBER/ORA, June 2021