Home » Proposed Rule Outlines Definitions, Requirements for Trial Sponsors
Proposed Rule Outlines Definitions, Requirements for Trial Sponsors
November 4, 2010
The rule as proposed doesn’t currently cover some applicants, although that is subject to change. Specifically, those not covered include petitioners filing a new drug application, new animal drug applications, biologic licensing applications and premarket approval of medical devices. These applicants are not covered because the FDA understands that not all applicants are involved in managing and conducting studies that support approval of a product.