[Federal Register Volume 63, Number 96 (Tuesday, May 19, 1998)]
[Notices]
[Pages 27583-27584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13314]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee for Pharmaceutical Science; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Advisory Committee for Pharmaceutical Science.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on June 23, 1998, 8 a.m. to
5 p.m., and on June 24, 1998, 8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Kimberly L. Topper, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration 5600 Fishers Lane,
Rockville, MD 20857, 301-443-5455, (For Federal Express Deliveries--
Chapman Bldg., 801 Thompson Ave., rm. 200, Rockville, MD 20857) or FDA
Advisory Committee Information Line,
[[Page 27584]]
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12539.
Please call the Information Line for up-to-date information on this
meeting.
Agenda: On June 23 and 24, 1998, the committee will focus on both
safety/efficacy and quality topics with a bridging topic (exposure).
Specific topics to be discussed include: (1) Nonclinical/nonhuman
pharmacology/toxicology research programs to support the drug
development and registration process, (2) in vitro drug metabolism to
support guidance updating, (3) the revision of the guidance for scale-
up and post-approval changes for immediate release drug products, and
(4) complex drug substances.
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 June 16, 1998.
Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11 a.m. on June 23, 1998, and between
approximately 10:15 a.m. and 10:45 a.m. on June 24, 1998. Time allotted
for each presentation may be limited. Those desiring to make formal
presentations should notify the contact person before June 16, 1998,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-13314 Filed 5-18-98; 8:45 am]
BILLING CODE 4160-01-F
