Grassley Questions FDA's Safety First Initiative

摘要

Sen. Chuck Grassley (R-Iowa) is requesting a briefing from the FDA on its Safety First Initiative to ensure the agency's new program to oversee drug safety is more than "cosmetic." The main goals of the initiative, announced in February by then-acting director of CDER, Janet Woodcock, include shifting the center's focus by redistributing resources and staff to pre-and postmarketing drug safety and providing as much focus, intensity of tracking, deadlines and accountability for postmarketing safety activities as for premarketing safety, efficacy and quality reviews (WDL, March 3).