October 2, 2017
- ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry (PDF - 105KB)
- ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry (PDF - 153KB)
- ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry (PDF - 221KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (PDF - 154KB)
- FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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