[Federal Register: October 18, 2002 (Volume 67, Number 202)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Peripheral and Central Nervous System Drugs
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 18 and 19,
2002, from 8 a.m. to 5 p.m.
Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave.,
Contact Person: Sandra Titus, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857,
301-827-7001, or e-mail Tituss@cder.fda.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area) code 12543. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On November 18, 2002, the committee will discuss the role
of brain imaging as an outcome measure in phase 3 trials of putative
therapeutic drugs for Alzheimer's disease; the discussions will not
focus on specific drugs or on specific applications to the agency. The
agency is considering whether brain imaging modalities can be utilized
as surrogate markers; that is, as primary outcomes in definitive
clinical trials to measure drug effect in lieu of clinical outcomes.
The committee will specifically discuss the following issues in
reference to each imaging modality:
1. How is the surrogate imaging modality best validated?
2. If one uses an imaging modality to support a disease-modifying
effect claim, how does one establish that such an effect occurs?
3. Has any surrogate imaging modality been validated at the present
4. Even if no surrogate imaging modality has currently been
validated, is it appropriate to use one or more such modalities as
primary or ancillary outcome measures of efficacy in phase 3 clinical
On November 19, 2002, the committee will consider a supplemental
new drug application (NDA) 20-306 for F-18 fluorodeoxyglucose (FDG)
positron emission tomography (PET) imaging proposed to diagnose and/or
identify progression of Alzheimer's disease and other forms of
dementia. This application is based on published multi-center
controlled clinical trials, additional information provided by some of
the literature authors, and other supportive literature. Considerations
will include the relevance of current practice, knowledge of
Alzheimer's disease process, and clinical trial design to establish
clinical usefulness of F-18 FDG PET in Alzheimer's disease. (Downstate
Medical Center, Peoria, IL, is the sponsor of the new drug application.
The Academy of Molecular Imaging provided the literature references and
the literature summary that formed the basis of the supplemental NDA.)
The background material will become available no later than the day
before the meeting and will be posted under the Peripheral and Central
Nervous Systems Drugs Advisory Committee docket site at: http://
www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and
scroll down to the Peripheral and Central Nervous Systems Drugs
Advisory Committee meetings.)
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by November 6,
2002. Oral presentations from the public will be scheduled between
approximately 11 a.m. and noon each day. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 6, 2002,
and submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Sandra Titus at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 10, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26613 Filed 10-17-02; 8:45 am]
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