What's New Related to Drugs

March 14, 2019

• A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry (PDF - 118KB)
• Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products Guidance for Industry (PDF - 576KB)
• FDA Drug Shortages
  • Flurazepam Hydrochloride Capsules (New - Currently in Shortage)
• Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry (PDF - 122KB)