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PREPARATION FOR THE INTERNATIONAL CONFERENCE ON HARMONIZATION
MEETINGS IN YOKOHAMA, JAPAN
DATE AND TIME: October 19, 1:30 p.m.
LOCATION: 5600 Fishers
Lane, 3rd Floor, Chesapeake Conference Room, Rockville,
MD.
CONTACT: Sema Hashemi, Office of the Commissioner,
301-827-3050. The purpose of the meeting is to solicit public
input prior to the next Steering Committee and Experts
Working Groups meetings in Yokohama, Japan on November
15 through 18, 2004, which discussion of the topics underway
and the future of ICH will continue. More Information
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
DATE AND TIME: October 19 and 20, 8:30
a.m.
LOCATION: FDA, Center for Drug Evaluation and Research
Advisory Committee Conference Rm. 1066, 5630 Fishers Lane,
Rockville, MD.
CONTACT: Hilda Scharen, Center for Drug
Evaluation and Research, 301-827-7001.On October 19, the
committee will do the following: receive updates pertaining
to the Manufacturing Subcommittee, the Parametric Tolerance
Interval Test (PTIT) Workshop, and the Good Manufacturing
Practices (GMPs) for the 21st Century Initiative, and review
and discuss research opportunities under the critical
Path Initiative. On October 20, the committee will do the
following: review and discuss the Office of Pharmaceutical
Science (OPS) plans and activities designed to take the
organization towards the "desired
state" of science and risk-based regulatory policies
and practices as articulated under the GMPs for the 21st
Century Initiative, and review and discuss specific topics
related to pharmaceutical equivalence and bioequivalence
of generic drugs. More
Information
BLOOD PRODUCTS ADVISORY COMMITTEE
DATE AND TIME: October 21, 8:00 a.m.
and October 22, 8:30 a.m.
LOCATION: Holiday Inn Gaithersburg,
Two Montgomery Village Ave., Gaithersburg, MD.
CONTACT: Linda A. Smallwood, Center for
Biologics Evaluation and Research, 301-827-3514. On October
21, the committee will hear updates on the following topics:
Summary of the Transmissible Spongiform Encephalopathies
Advisory Committee (TSEAC) meeting discussion of new variant
Creutzfeldt-Jacob disease (vCJD) transmission by transfusion
in the United Kingdom and supplemental testing for human
immunodeficiency virus (HIV) and hepatitis C virus (HCV).
On October 22, the committee will hear updates on these
topics: a summary of the Plasma Workshop held on August
31 through September 1, 2004, draft uniform donor health
questionnaire acceptance guidance: review of public comments,
and FDA current thinking on monitoring weight in source
plasma donors. More Information
CLINICAL PHARMACOLOGY SUBCOMMIITTEE OF THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
DATE AND TIME: November 3
and November 4, 8:00 a.m.
LOCATION: Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD.
CONTACT: Hilda Scharen, Center for Drug Evaluation and Research, 301-827-7001. On
November 3, the subcommittee will: Receive topic updates for ongoing FDA activities previously presented to the subcommittee; discuss and provide comments on the evidence for updating labels of approved drugs to include integrating pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose of optimizing therapeutic response and reducing risks of toxicity; and discuss and provide comments on metabolism-and transporter-based drug interactions included as recommendations in a draft guidance for industry being prepared by FDA. On
November 4, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of the transition of biomarkers to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints. More
Information
STIMULATING INNOVATION IN MEDICAL TECHNOLOGIES
DATE AND TIME: November 8, 9:30 a.m.
LOCATION: Hubert H. Humphrey Building, Rm. 800, 200 Independence Ave.,
SW., Washington, DC.
CONTACT: Nancy Stanisic, Food and Drug
Administration, 301-827-1660. The purpose of this public
meeting is to obtain input from interested persons on what
steps HHS can take to create or enhance coordination across
HHS agencies in order to stimulate the development of new technologies.
More Information
SECOND ANNUAL STAKEHOLDER MEETING ON THE IMPLEMENTATION
OF THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF
2002 PROVISIONS
DATE AND TIME: November 18, 9:00 a.m.
LOCATION: Marriott Gaithersburg
Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD.
CONTACT: Cindy Garris, Center for Devices
and Radiological Health, 301-443-6597. The topic of discussion
is the agency's progress
in implementing the various MDUFMA Provisions, including
the guidances FDA has issued on the new law. More
Information
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