Business · 25/09/2018Updated: 10/17/2026 · 1 min read

Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability

The Food and Drug Administration (FDA) has released a draft guidance outlining the principles and practices for reviewing new drug applications and biologics license applications, aiming to improve the efficiency of the review process. This revised guidance supersedes the 2005 guidance for review staff and industry, providing a framework for review staff and applicants to support a robust review process.