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What's New on the FDA Drugs Site
November 20, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Ninlaro (ixazomib), new oral medication to treat multiple myeloma
- FDA Drug Shortages
- Sumatriptan (Imitrex) Nasal Spray (New - Currently in Shortage)
- From our perspective: Ensuring the safety and effectiveness of sunscreens
- Guidance for Industry
- Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF - 107KB)
- Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry (PDF - 421KB)
- Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process Guidance for Industry (PDF - 107KB)
- Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions To Support a GRASE Determination Under the Sunscreen Innovation Act (PDF - 124KB)
Guidance for Industry
- National Drug Code Directory
- Postmarketing Requirements and Commitments: Downloadable Database File (updated)
- Postmarket Requirements and Commitments Search (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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