Healthy Skepticism Library item: 9393

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

FDA user fees approved.
Clin Pharm. 1993 Jan; 12:(1):3

Abstract:

The approval of the Prescription Drug User Fee Act of 1992, a plan for the Food and Drug Administration (FDA) to charge fees to pharmaceutical companies for review of their new drug applications, is announced. Initially, the fee charged for each new drug application is $100,000; 5 yr from now, it will be $233,000. The legislation will also require manufacturers to pay FDA an annual fee for every drug they have on the market; the fee is $6,000 now and will rise to $14,000 in 5 yr.

Keywords:
Drug Approval* Drug Industry/economics* Drug Industry/legislation & jurisprudence Fees and Charges* Humans Prescriptions, Drug/economics Time Factors United States United States Food and Drug Administration/legislation & jurisprudence*