What's New on the FDA Drugs Site
June 20, 2017
- Drug Approval Package: Radicava (edaravone) Injection
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA issues warning about body-building products labeled to contain steroid and steroid-like substances
- National Drug Code Directory
- REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) (PDF - 123KB)
- Single Entity Injectable Drug Products
- Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 (PDF - 240KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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