Healthy Skepticism Library item: 9309

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Henkel J.
User fees to fund faster reviews.
FDA Consum 1993 Oct; 27:(8):19-21

Abstract:

The impact of the resources provided by the Prescription Drug User Fee Act of 1992 on the shortening of review time of drugs at the Food and Drug Administration over the next 5 yr is discussed. The hiring of new employees, the acceleration of the review process, the role of the pharmaceutical industry, the fee structure and estimates for fiscal years 1993 through 1997, and reasons for waivers or reductions are outlined.

Keywords:
Drug Approval/economics* Fees and Charges* United States United States Food and Drug Administration/economics United States Food and Drug Administration/organization & administration*