October 25, 2017
- CDER Conversation: Evaluating the Risk of Drug-Drug Interactions
- Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry (PDF - 225KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Dextrose 5% Injection Bags (New - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (New - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies Guidance for Industry (PDF - 397KB)
- National Drug Code Directory (updated)
- Videos and Podcasts on Regulatory Science at CDER: Lynn Yao Transcript
- Videos and Podcasts on Regulatory Science at CDER: Michael Ngyuen, M.D. Transcript
- Videos and Podcasts on Regulatory Science at CDER: Karen Mahoney Transcript
- Videos and Podcasts on Regulatory Science at CDER: Lynn Yao Podcast
- Videos and Podcasts on Regulatory Science at CDER: Michael Ngyuen, M.D. Podcast
- Videos and Podcasts on Regulatory Science at CDER: Karen Mahoney Podcast
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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