[Federal Register Volume 70, Number 61 (Thursday, March 31, 2005)]
[Notices]
[Pages 16507-16508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6404]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0317] (formerly Docket No. 03D-0317)
Guidance for Review Staff and Industry on Good Review Management
Principles and Practices 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 guidance for review staff and industry entitled
``Good Review Management Principles and Practices 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).
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of this 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 guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. The guidance may also be obtained from
CBER by mail by calling 1-800-835-4709, or 301-827-1800. Submit
electronic comments to http://www.fda.gov/dockets/ecomments. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: John Jenkins, Center for Drug
Evaluation and Research (HFD-020), Food and Drug Administration, suite
7215, 5515 Security Lane, Rockville, MD 20852, 301-594-3937; or Robert
A. Yetter, Center for Biologics Evaluation and Research (HFM-25), Food
and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-
827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for review staff
and industry entitled ``Good Review Management Principles and Practices
for PDUFA Products.'' In conjunction with the June 2002 reauthorization
of PDUFA, FDA agreed to meet specific performance goals (PDUFA Goals).
The PDUFA Goals include providing guidance to industry and review staff
in CDER and CBER on the good review management principles and practices
(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. The GRMPs also clarify roles and responsibilities of review
staff in managing the review process and identify ways in which NDA and
BLA applicants may further the effectiveness and efficiency of the
review process.
In the Federal Register of July 28, 2003 (68 FR 44345), FDA
published a notice announcing the availability of a draft version of
this guidance. FDA received a number of comments when it issued the
draft version of this guidance. We have considered the comments on the
draft guidance carefully and have made some changes to address those
comments. The guidance has been revised to clarify the principles on
which our current and developing practices are based. We have also
added general internal timelines for important milestones associated
with the review process.
The GRMPs also include the agency's current best practices, as well
as goals for review management improvements. The GRMPs are an important
foundational component of FDA's program to more fully implement a
quality systems approach for the new drug and biologics review and
approval process.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 guidance at any
time. 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
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.
[[Page 16508]]
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6404 Filed 3-30-05; 8:45 am]
BILLING CODE 4160-01-S