October 12, 2017
- Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (PDF - 96KB)
- Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry (PDF - 147KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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