May 31, 2018
- Development of a Shared System REMS Guidance for Industry (PDF - 99KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- El riesgo de sufrir un trastorno sanguíneo grave y potencialmente mortal insta a la FDA a tomar una medida en cuanto a los productos orales de venta libre a base de benzocaína, utilizados para la dentición y el dolor de boca, y los anestésicos locales recetados
- FDA Drug Shortages
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- National Drug Code Directory (updated)
- Waivers of the Single, Shared System REMS Requirement Guidance for Industry (PDF - 91KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex [Guidance for Industry] (PDF - 223KB
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