[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Page 8381]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005D-0057]

Reviewer Guidance on Conducting a Clinical Safety Review of a New 
Product Application and Preparing a Report on the Review; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a reviewer guidance entitled ``Conducting a Clinical 
Safety Review of a New Product Application and Preparing a Report on 
the Review.'' The guidance is intended to provide an annotated outline 
of the safety component of a clinical review of a new drug or biologic 
product application and guidance on how to conduct and organize the 
safety review. The guidance is also intended to provide standardization 
and consistency in the format, content, and quality of safety reviews. 
This reviewer guidance has been developed as part of the agency's good 
review practices initiative.

DATES: General comments on agency guidance documents are welcome at any 

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. 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. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug 
Evaluation and Research (HFD-40), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6758.

SUPPLEMENTARY INFORMATION: This good review practice (GRP) guidance is 
intended to assist reviewers conducting clinical safety reviews as part 
of the new drug application (NDA) and biologics license application 
(BLA) review process. The guidance provides standardization and 
consistency in the format and content of safety reviews and will help 
ensure that critical presentations and analyses are not inadvertently 
omitted. The standardized structure of this guidance will enable 
subsequent reviewers and other readers to readily locate specific 
safety information. This guidance is entirely compatible with the 
clinical review template, which has been developed in the Center for 
Drug Evaluation and Research for use by application reviewers. The 
guidance is structured as an annotated outline to corrolate exactly 
with the section headings of the review template, providing the 
pertinent guidance under each heading. The commentary and suggestions 
under each section of the guidance, together with appended examples, 
provide suggested analyses, methods of presentations, and discussion of 
special cases and potential difficulties.
    In 1996, FDA announced the availability of the draft version of 
this guidance. A number of comments were received, and the agency 
considered them carefully as it finalized the guidance. The changes 
that were made to the guidance were intended primarily to make it 
consistent with the template reviewers are using to evaluate marketing 
applications. Some minor clarifying changes also were made.
    This level 1 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 this topic. 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 statute and regulations.
    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.
    Persons with access to the Internet may obtain the guidance at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: February 10, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3181 Filed 2-17-05; 8:45 am]