BioCentury
ARTICLE | Regulation

Expect some delays II

April 28, 2008 7:00 AM UTC

Regulation

FDA last week received direct hiring authority for a number of key jobs essential to the review and oversight of new drugs. But while the move will help the agency fill vacant slots in the Office of New Drugs (OND) and other parts of the agency more quickly, it will take FDA years to absorb and train new employees, and new safety mandates imposed by Congress will continue to compete for resources with the agency's PDUFA objectives...