User fee guidelines nearing release

WASHINGTON - The FDA plans to begin releasing guidelines for user fees this month in anticipation of the imposition of the fees late this summer.

The Prescription Drug User Fee Act of 1992 authorized the fees to support FDA efforts to speed up the drug approval process. However, the agency has yet to collect $36 million in fees for the 1993 fiscal year ending in October because Congress still hasn't passed the FDA's user fee supplemental appropriation bill...