What's New Related to Drugs

April 24, 2019

• FDA Drug Shortages
  • Cetirizine Hydrochloride (New - Discontinuation)
  • Thiothixene Capsules (New - Currently in Shortage)
• Guidance for Industry
  • Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 209KB)
  • Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry (PDF - 67KB)
• Manual of Policies and Procedures (MAPP) 5017.4 Center for Drug Evaluation and Research Biopharmaceutics Council (PDF - 117KB)