Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled "Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications." This draft guidance describes the fundamental values and operational principles that serve as the foundation for the review process. It also clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. This draft guidance revises the guidance for review staff and industry entitled "Good Review Management Principles and Practices for PDUFA Products" issued April 2005.