CDER New April 9, 2018

April 6, 2018

• FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• Draft Guidance:   Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs (PDF - 138KB)
• Draft Guidance: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (PDF - 90KB)
• Drug Trials Snapshots: ILUMYA
• FDA Drug Shortages
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Ketamine Injection (New - Currently in Shortage)
• Inactive Ingredient Search for Approved Drug Products Search
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)