Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry

Issue Date: November 21, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees,
Status: Final

Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry

This guidance for industry explains how the Agency will issue and use information request (IR) letters and discipline review (DR) letters during the review of products in original human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) (PDUFA products). This guidance does not apply to supplemental applications, resubmissions, or to applications for non-PDUFA products.

Download the Guidance Document