December 28, 2017
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development Guidance for Industry and Review Staff Good Review Practice (PDF - 191KB)
- Drug Approval Package: Mepsevii (vestronidase alfa-vjbk) Injection
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry (PDF - 156KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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