Regulatory Information
Food and Drug Administration Safety and Innovation Act
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Food and Drug Administration Safety and Innovation Act (FDASIA) How to Make a FOIA Request - Guidelines for making a Freedom of Information Act request for public information
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How to Make a FOIA Request Federal Food, Drug, and Cosmetic Act
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Federal Food, Drug, and Cosmetic Act (FD&C; Act)
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The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.
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Resources for You
Recently Posted Guidance Documents
- 12/03/2018 - Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA - Final
- 12/03/2018 - Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment - Final
- 11/30/2018 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/30/2018 - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/29/2018 - Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/29/2018 - Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/14/2018 - CVM GFI #243 (VICH GL56) Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods - Final
- 11/13/2018 - Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials - Draft
- 11/06/2018 - Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry - Final
- 11/06/2018 - Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry - Draft
Spotlight
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Food and Drug Administration Safety and Innovation Act (FDASIA) International Council for Harmonisation (ICH) Guidance Documents Veterinary International Conference on Harmonization (VICH) Guidance Documents Clinical Investigators - Disqualification Proceedings
Rulemaking
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