What's New on the FDA Drugs Site
December 28, 2016
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
- Drug Trials Snapshot: EUCRISA—Treatment of mild to moderate atopic dermatitis in patients 2 age years of age and older
- CDER Statement: FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 349KB)
- Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF - 107KB)
- Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF - 122KB)
- Botanical Drug Development: Guidance for Industry (PDF - 221KB)
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF - 150KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- 483: Divi's Laboratories (PDF - 8.7MB)
- National Drug Code Directory
- Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry (PDF - 85KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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