June 12, 2018
- Generic Drug Review Dashboard Report (updated)
- Generic Drug User Fee Amendments (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- GDUFA Implementation Quarterly Meetings between FDA and Industry (updated)
- FDA Drug Shortages
- Lamotrigine Tablets (New - Discontinuation)
- Internet Pharmacy Warning Letters (Updated)
- FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
- Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (PDF - 128KB)
- Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry (PDF - 1MB)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 458KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF - 524KB)
.png)
No hay comentarios:
Publicar un comentario