January 18, 2018
- 2018 Compounding Policy Priorities Plan
- CDER and You: Keys to Effective Engagement
- FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials (updated)
- AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry (PDF- 553KB) - Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry (PDF - 469KB) - Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Dronabinol Capsules (New - Discontinuation)
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate (LOESTRIN Fe) Tablets (New - Discontinuation)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (PDF - 680KB)
- Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry (PDF - 556KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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