September 28, 2017
- Opioid Medications (updated)
- Risk Evaluation and Mitigation Strategy (REMS) for Opioid Analgesics (updated)
- Historical Information on REMS for Opioid Analgesics (updated)
- Director's Corner Podcast: FDA's Adverse Event Reporting System (FAERS)
- FDA Press Release: FDA improves access to reports of adverse drug reactions
- FDA Adverse Events Reporting System (FAERS) Public Dashboard
- Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB)
- Drug Trials Snapshot: SOLOSEC
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Verzenio (abemaciclib), a new treatment for certain advanced or metastatic breast cancers
- FDA Drug Shortages
- Carbidopa and Levodopa Extended Release Tablets (New - Currently in Shortage)
- Diazepam Injection, USP (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
- Manual of Policies and Procedures (MAPP)
- National Drug Code Directory (updated)
- Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry (PDF - 122KB)
- Presentations
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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