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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- 11/30/2018 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/30/2018 - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff - Draft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Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff - Draft
- 11/29/2018 - Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff - Draft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
- Search all FDA official Guidance Documents and other regulatory guidance
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
- Comment on proposed regulations and submit petitions
- Unified Agenda of Regulations: Upcoming FDA regulations
- Unified Agenda-TRACK: Search for information on upcoming FDA regulations
- HHS Regulations: Search top HHS regulations, and find and comment on other HHS rules
- HHS Regulation Toolkit: Learn more about regulations and how you can make your voice heard