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GUIDANCE DOCUMENT

Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act Guidance for Industry November 2001

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.