CDER New May 18, 2016

What's New on the FDA Drugs Site

May 17, 2016

• Manual of Policies and Procedures (MAPP)
  • 7400.1 Rev. 2 Management of the CDER Pharmacology/Toxicology Coordinating Committee and
    Its Associated Subcommittees and Working Groups (PDF - 118KB)
  • 5016.1 Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review (PDF - 65KB)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Shortages
  • Cefepime Injection   (Updated - Currently in Shortage)
  • Epinephrine Injection   (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection   (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP, CII, (Preservative-Free)(For PCA Use Only)   (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP   (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP   (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection   (Updated - Currently in Shortage)
  • Sufentanil Citrate (Sufenta) Injection   (Updated - Currently in Shortage)
• FDA Drug Safety Podcast:
  • FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
  • FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)