Recently Issued Guidance Documents
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VDosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
CDER/CBER, January 2023 -
Format and Content of a REMS Document; Guidance for Industry
CDER/CBER, January 2023 -
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe; Guidance for Industry
CDER/CBER, December 2022 -
Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
CDER/CBER, December 2022 -
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2022 -
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
CBER, December 2022 -
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, November 2022 -
Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry
CDER/CBER/OCE, November 2022 -
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry
CBER, November 2022 -
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry
CDER/CBER/OCLiP/OCE, November 2022 -
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide; Guidance for Industry
CBER, November 2022 -
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry
CDER/CBER, November 2022 -
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, October 2022 -
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, October 2022 -
Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry
CBER, October 2022 -
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA; Guidance for Industry
CDER/CBER, October 2022