February 28, 2018
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry (PDF - 484KB)
- Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170KB)
- Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (PDF - 283KB)
- Drug Supply Chain Security Act (DSCSA) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Diltiazem Hydrochloride (New - Currently in Shortage)
- Ketamine Injection (New - Currently in Shortage)
- Peginterferon alfa-2b (Sylatron) (New - Discontinuation)
- Sterile Water (Updated - Currently in Shortage)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- US FDA and Health Canada: Joint Regional Consultation on the ICH (updated)
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