[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 A working draft of that guidance, ``Draft Guidance for 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receive written comments, data, information, or views on the draft 
guidance or the workshop.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    Three weeks prior to the workshop, a copy of the draft guidance for 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