Zdrowie i gospodarka · 17/06/2003

FDA Announces Draft Guidance for Continuous Marketing Applications Pilot 2

The FDA is releasing a draft guidance outlining how it will engage in frequent scientific feedback and interactions with pharmaceutical companies during the development of Fast Track products, as part of a pilot program under the Prescription Drug User Fee Act (PDUFA). The agency is seeking applicants to participate in the Pilot 2 program.