Zdrowie i gospodarka · 06/10/2003

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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA." This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA). This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of development for certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot 2 program.