Guidance for Industry on Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.'' The purpose of this guidance is to clarify what clinical evidence of effectiveness should be provided in new drug applications, biological product license applications, and supplemental applications for new uses of drugs and biologics. The guidance is also intended to fulfill the requirements of certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).