[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Notices]
[Pages 60713-60714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30509]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0443]
Review of Clinical Safety Data in Marketing Applications; Notice
of Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop, as part of its ``good review practices'' (GRP's), to provide
an opportunity for input from the pharmaceutical industry, academia,
and the public on the principles and methods being used by FDA in the
review of clinical safety data in new drug product applications.
Information and ideas generated at the workshop will be used to develop
a guidance for reviewers who participate in the agency's clinical
review process. A working draft of that guidance, ``Draft Guidance for
Reviewers: Conducting a Clinical Safety Review of a New Product
Application and Preparing a Report on the Review,'' along with a
tentative
[[Page 60714]]
workshop agenda, will be available 3 weeks before the workshop.
DATES: The public workshop will be held on Wednesday, December 18,
1996, from 8:30 a.m. to 5 p.m. Because space is limited, interested
parties are encouraged to register as soon as possible, or at least by
December 13, 1996. There is no registration fee for the workshop. The
administrative docket will remain open until January 31, 1997, to
receive written comments, data, information, or views on the draft
guidance or the workshop.
ADDRESSES: The public workshop will be held at the DoubleTree Hotel,
1750 Rockville Pike, Rockville, MD. Persons interested in attending can
register by faxing their name and title, organization name, if any,
address, telephone and fax numbers to Paul A. David at FAX 301-594-
2859.
Three weeks prior to the workshop, a copy of the draft guidance for
reviewers, along with a tentative workshop agenda, will be available
through CDER's Fax-on-Demand, 301-827-0577 or 800-342-2722, under the
index, document no. 0506. Information on the workshop and registration
also will be available via the Internet using the World Wide Web (WWW).
To connect to the CDER home page, type http://www.fda.gov/cder and go
to the ``What's Happening'' section. A transcript of the workshop will
be available from the Freedom of Information Office (HFI-35), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 business days after the workshop at a cost of 10 cents
per page.
Written comments on the draft reviewer guidance or on the workshop
can be submitted until January 31, 1997, to the Dockets Management
Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
Two copies of 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. Received comments
may be viewed at the Dockets Management Branch between 9 a.m. and 4
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Paul A. David, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-120), 5600
Fishers Lane, Rockville, MD 20857, 301-594-5530.
SUPPLEMENTARY INFORMATION: In March 1994, FDA launched a major
initiative to develop and implement GRP's. The goal of the GRP's
initiative is to identify and implement methods for improving the
quality and efficiency of the clinical reviews of new product
applications.
To manage this large initiative, the agency developed a multitrack
plan to be implemented in stages. Tasks currently under development
include: Defining the critical elements of the clinical review;
designing a process for feedback, evaluation, and evolution in review
practices and procedures; developing a data base on regulatory policy
for clinical review; and defining good data handling practices.
The December 18, 1996, workshop is a part of an effort to define
the critical elements of the clinical safety review process and develop
a guidance for reviewers that describes those elements and sets
institutional expectations for each level of review. The guidance being
developed is intended for use by agency officers and other clinical
reviewers during the review of new drug product applications. The draft
guidance will be discussed at the workshop.
The primary goal of the workshop is to provide an opportunity for
input from industry, academia, and the public on the principles and
methods for the review of clinical safety data in new drug
applications. To encourage the exchange of ideas and comments, the day-
long workshop has been divided into the following four major sessions:
(1) Characterizing the exposed population, establishing the common
adverse events profile, establishing the serious adverse events
profile, and integrating important safety findings using the review of
systems approach. Each session will include a panel discussion and a
period at the end for public comment.
The agency hopes to answer the following questions during the
workshop: (1) What approaches to safety data review could speed the
overall review process? (2) What steps could be taken to standardize
the presentation of safety review data? (3) Are there review or review-
related issues that are especially troublesome for those submitting
safety data? (4) Do some approaches to data presentation make the
reviewer's job easier or more difficult?
As it proceeds with the finalization of the guidance for reviewers,
the agency will consider carefully all data and information presented
at the workshop and submitted in writing on the guidance and workshop
Dated: November 21, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-30509 Filed 11-27-96; 8:45 am]
BILLING CODE 4160-01-F
