December 21, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
- FDA Drug Shortages
- Albiglutide (Tanzeum) Injection (New - Discontinuation)
- Progesterone Injection, USP (New - Currently in Shortage)
- FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer.mp3
- FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer (Transcript)
- Elemental Impurities
- Pharmaceutical Quality Resources (updated)
- Manual of Policies and Procedures (MAPP)5017.2 Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance (PDF - 125KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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