Zdrowie i gospodarka · 19/11/2004

Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Extension of Application Deadline

The Food and Drug Administration (FDA) is announcing an extension for acceptance of applications to its continuous marketing applications (CMA) Pilot 2 program implemented under the guidance for industry entitled "Continuous Marketing Applications: Pilot 2- Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA." The extension applies only to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) review divisions that have not received acceptable applications for participation in the Pilot 2 program.