[Federal Register: November 18, 2002 (Volume 67, Number 222)]
[Notices]
[Page 69534-69535]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no02-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System Drugs Advisory Committee;
Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing an amendment
to the notice of a meeting of the Peripheral and Central Nervous System
Drugs Advisory Committee. This meeting was announced in the Federal
Register of October 18, 2002 (67 FR 64400). The amendment is being made
to reflect a change in the Date and Time and Agenda portions of the
meeting. The meeting was originally scheduled for November 18 and 19,
2002. However, due to administrative complications, the discussions on
November 19, 2002, will be postponed until a later date. There are no
other changes.
FOR FURTHER INFORMATION CONTACT: 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 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2002
(67
[[Page 69535]]
FR 64400), FDA announced that a meeting of the Peripheral and Central
Nervous System Drugs Advisory Committee would be held on November 18
and 19, 2002. On page 64400, in the second column, the Date and Time
and Agenda portions of the meeting are amended to read as follows:
Date and Time: The meeting will be held on November 18, 2002, from
8 a.m. to 5 p.m.
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
time?
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
trials?
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 13, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-29294 Filed 11-14-02; 1:54 pm]
BILLING CODE 4160-01-S