03-19026. Draft Guidance for Reviewers and Industry on Good Review Management Principles for Prescription Drug User Fee Act Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for reviewers and industry entitled “Good Review Management Principles for PDUFA Products.” 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). The good review management principles (GRMPs) are intended to promote efficient and consistent management of application reviews. The GRMPs focus on the role of both reviewers and industry, emphasizing effective communication to enhance the drug development and review processes.

DATES:

Submit written or electronic comments on the draft guidance by September 11, 2003. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communications, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Food and Drug Administration, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

John Jenkins, Center for Drug Evaluation and Research (HFD-020), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-3937; or Robert A. Yetter, Center for Biologics Evaluation and Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for reviewers and industry entitled “Good Review Management Principles for PDUFA Products.” This document is intended to provide guidance to industry and the review staff in CDER and CBER on GRMPs for the conduct of the first-cycle review of a new drug application (NDA), a biologics license application (BLA), or an efficacy supplement under PDUFA. The GRMPs in this guidance are based on the collective experience of CDER and CBER with review of applications for PDUFA products and are intended to promote efficient and consistent management of application reviews. A key aspect of GRMPs is their emphasis on effective communication between the agency and applicants throughout the drug and biologic product development and review processes.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on GRMPs for PDUFA products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: July 18, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.