October 19, 2017
- Videos and Podcasts on Regulatory Science at CDER
- Videos and Podcasts on Regulatory Science at CDER: Celia Cruz, Ph.D. – Transcript
- Videos and Podcasts on Regulatory Science at CDER: Lisa LaVange Transcript
- Videos and Podcasts on Regulatory Science at CDER: Raj Madabushi, Ph.D.—Transcript
- Videos and Podcasts on Regulatory Science at CDER: David Strauss, M.D., Ph.D.—Transcript
- Videos and Podcasts on Regulatory Science at CDER: Kimberly Witzmann, M.D.—Transcript
- DRAFT Agenda - Geriatric Oncology Workshop (PDF - 111KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Pantoprazole (Protonix) Powder for Injection (Updated - Currently in Shortage)
- Procainamide Hydrochloride Injection, USP (New - Currently in Shortage)
- Sumatriptan (ZECUITY®) Iontophoretic Transdermal System (New - Discontinuation)
- List of Determinations Including Written Request (updated)
- National Drug Code Directory (updated)
- Product Specific Guidances for Generic Drug Development (Updated) [32 New; 19 Revisions]
- Product-Specific Guidance for Tiotropium Bromide
- Product-Specific Guidances for Salmeterol Xinafoate and Fluticasone Propionate (Aerosol) and Fluticasone Proprionate (powder)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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