[Federal Register: July 28, 2003 (Volume 68, Number 144)]
[Notices]
[Page 44345-44346]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy03-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0317]
Draft Guidance for Reviewers and Industry on Good Review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.
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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availability of a draft guidance for reviewers and industry entitled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DATES: Submit written or electronic comments on the draft guidance by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.
[[Page 44346]]
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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Submit written comments on the draft guidance to the Division of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INFORMATION section for electronic access to the draft guidance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.
[FR Doc. 03-19026 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S