November 03, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL
- FDA Drug Shortages
- Hydromorphone Hydrochloride Injection, USP (New - Currently in Shortage)
- Morphine Sulfate Injection, USP (New - Currently in Shortage)
- Pantoprazole (Protonix) Powder for Injection (New - Currently in Shortage)
- Scopolamine (Transderm Scop) Transdermal System Patch (Updated - Resolved)
- Phonetic and Orthographic Computer Analysis (POCA) program (updated)
- Opioid Medications (updated)
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
- REMS and Continuing Education for Health Care Providers (PDF - 228KB)
- ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 152KB)
- Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff (PDF - 215KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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