FDA DEVICE REVIEW FUNDING INCREASE OF $5.2 MIL. COULD PAY FOR OUTSIDE CONTRACTS TO IMPROVE PMA TIMES, AGENCY STAFFERS SAY; REP. SKEEN CRITICIZES "PHONY" USER FEES
This article was originally published in The Gray Sheet
Executive Summary
FDA contracting out review of premarket approval application efficacy data to external groups is possible under the agency's fiscal year 1998 budget proposal, staffers say. Under the budget, FDA would apply a $5.2 mil. boost in premarket evaluation funding to improving PMA and PMA supplement review times.