CDER New September 29, 2017

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)
  • 5015.12 Process for Evaluating Emerging Technologies Related to Quality (PDF - 83KB)
  • 5220.3 Communicating Certain Deficiencies Identified During Filing Review of ANDAs (PDF - 70KB)
• National Drug Code Directory (updated)
• Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry (PDF - 122KB)
• Presentations
  • FDA's Role in Confronting the Opioid Epidemic (PDF - 818KB)
  • The Collaborative for Effective Prescription Opioids quarterly meeting on September 12, 2017 (PDF - 336KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)