April 23, 2018
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry (PDF - 84KB)
- Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (PDF - 86KB)
- Drug Safety and Risk Management Advisory Committee Roster (updated)
- FYs 2013 - 2017 GDUFA Science and Research Report: Transdermal Drug Products
- Outsourcing Facilities (updated)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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