December 15, 2017
- List of Determinations Including Written Request (updated)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (PDF - 659KB) and (XLS - 30KB)
- Phonetic and Orthographic Computer Analysis (POCA) program (updated)
- Manual of Policies and Procedures (MAPP) 5220.5 Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications (PDF - 227KB)
- Drug Approval Package: Bortezomib Injection
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- L-Cysteine Hydrochloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Information Requests and Discipline Review Letters Under GDUFA Guidance for Industry (PDF - 81KB)
- Drug Products, Including Biological Products, that Contain Nanomaterials; Guidance for Industry (PDF - 235KB)
- Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry (PDF - 75KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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