Zdrowie i gospodarka · 17.06.2003
Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1-Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Act
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products Under PDUFA."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). Pilot 1 will enable certain applicants to receive early feedback on portions of their applications. Pilot 1 will also evaluate the benefits and costs of providing applicants early feedback.