From the FDA site: Calendar For Oct 4-14
Updated September 30, 1999 12:22 PM
This area includes meetings and events that are related to CDER's mission.
CENTER FOR DRUG EVALUATION AND RESEARCH
FOOD AND DRUG ADMINISTRATION
ADVISORS AND CONSULTANTS STAFF
October 1999 Meetings
ANTIVIRAL DRUGS ADVISORY COMMITTEE
October 4, 1999, from 8 a.m. to 5 p.m., and on October 5, 1999, from 8 a.m. to 12 m., Gaithersburg Holiday Inn, The Ballrooms, 2 Montgomery Village Avenue, Gaithersburg, Maryland.
ADDITIONAL INFORMATION: Rhonda W. Stover or John Schupp, Center for Drug Evaluation and Research, HFD-21, (301) 827-7001, Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on October 4, 1999.
AGENDA: On the morning of October 4, 1999, presentations and committee discussions will address issues related to the potential applicability of information from non-U.S. studies of prevention of perinatal HIV (Human Immunodeficiency Virus) transmission to U.S. clinical settings.
CLOSED COMMITTEE DELIBERATIONS: On October 4, 1999, from 2 p.m to 5 p.m., and on October 5, 1999, from 8 a.m. to 12 m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information relevant to pending investigational new drug applications and drug development plans. (5 U.S.C. 552b(c)(4)).
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
fda.gov
October 8, 1999, from 8 a.m. to 4:30 p.m., Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, MD., phone number is 301-652-2000.
ADDITIONAL INFORMATION: Sandra Titus, Center for Drug Evaluation and Research (HFD-21), 301-827-7001, or e-mail TITUSS@CDER.FDA.GOV. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m.
AGENDA: The committee will consider the safety and efficacy of new drug application (NDA) 19-839, supplement 026, Zoloft®, (sertraline hydrochloride, Pfizer Pharmaceuticals) proposed to treat posttraumatic stress disorder.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
October 14, 1999, 9 a.m. to 5:30 p.m., National Institutes of Health, Clinical Center, Building 10, Jack Masur Auditorium, 9000 Rockville Pike, Bethesda, MD. Parking in the Clinical Center is reserved for Clinical Center patients and their visitors. If you must drive, please use an outlying lot such as Lot 41B. Free shuttle bus service is provided from Lot 41B to the Clincal Center every eight minutes during rush hour and every fifteen minutes at other times.
ADDITIONAL INFORMATION: Joan C. Standaert, Center for Drug Evaluation and Research, (HFD-110), 419-259-2511, or John Treacy, 301-827-7001, Oral presentations from the public will be scheduled on October 14, 1999, between approximately 9 a.m. and 10 a.m.
AGENDA: On October 14, 1999, the committee will discuss acute coronary syndromes.
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