CDER New July 31, 2017

What's New on the FDA Drugs Site

July 28, 2017

• FDA alerts health care professionals of adverse events associated with Guardian’s compounded triamicinolone and moxifloxacin product for intravitreal injection 
• FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer
  FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer.
• Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Office of Antimicrobial Products Research Activities (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA) (updated)