U.S. Food and Drug Administration
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Upcoming Meetings

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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