Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.

Should you find a link that does not work within any Guidance document, Rule or other document 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.

Recently Issued Guidance Documents

Biologics

Search Some table information

Topic Administrative / Procedural Adverse Event Reporting Advertising Advisory Committees Allergenics Antimicrobial Resistance Aquaculture Biostatistics Biotechnology Blood Bovine Spongiform Encephalopathy (BSE) Cellular & Gene Therapy Chemistry, Manufacturing, and Controls (CMC) Clinical – Antimicrobial Clinical – Medical Clinical – Pharmacology Combination Products Compliance Current Good Manufacturing Practice (CGMP) Electronic Submissions Emergencies Environmental Safety Export FDA Amendments Act (FDAAA) FDA Reauthorization Act of 2017 (FDARA) FDA Safety and Innovation Act (FDASIA) Food & Drug Administration Modernization Act of 1997 Food and Beverage Safety Food Safety Modernization Act (FSMA) Good Clinical Practice (GCP) GUDID Human Food Safety Import Ingredients Inspection International Investigation & Enforcement Labeling Microbiology Nanotechnology Outbreak Packaging Pharm / Tox Postmarket Potential Metal or Chemical Contaminant Premarket Rare Diseases Real World Data / Real World Evidence (RWD/RWE) Recalls Records Registration Safety – Issues, Errors, and Problems Sanitation Technology & Discipline Tissue Transportation User fees Vaccines Xenotransplantation

Issue Date Last 7 days Last 30 days Last 60 days Last 90 days

Comment Closing Date on Draft* Last 7 days Last 30 days Last 60 days Last 90 days Next 7 days Next 30 days Next 60 days Next 90 days