FDA Calendar

Jan. 26-28, San Francisco

2006 GASTROINTESTINAL CANCERS SYMPOSIUM

Includes presentation from Adventrx Pharmaceuticals Inc. on phase 2 data for CoFactor, used to enhance activity and reduce associated toxicity of cancer chemotherapeutic 5-fluorouracil

Feb. 8, Silver Spring, Md.

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE (FDA)

Committees to discuss risk assessments for potential exposure to the variant Creutzfeldt-Jakob disease agent in plasma products, risk from investigational coagulation Factor XI manufactured in 1990s from plasma of U.K. donors and potential deferral of blood and plasma donors for history of transfusion from France and other European countries

Feb. 8-9, Houston

INDUSTRY EXCHANGE WORKSHOP ON FOOD AND DRUG ADMINISTRATION CLINICAL TRIAL REQUIREMENTS (FDA)

Workshop for clinical research community that targets sponsors, monitors, clinical investigators and institutional review boards

Feb. 14-15, Rockville, Md.

PEDIATRIC ADVISORY COMMITTEE (FDA)

Committee to discuss agency report on adverse event reporting for Lotensin, Brevibloc, Malarone, Viracept, Xenical and Glucovance; risk evaluation, labeling, risk communication and dissemination of information on potential cancer risk among pediatric patients treated for atopic dermatitis with topical dermatological immunosuppresants

Feb. 16-17, Bethesda, Md.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE (FDA)

Committee to review and discuss selection of strains to be included in the influenza virus vaccine for the 2005-2006 season; updates on FDA critical path initiative and research programs in the Center for Biologics Evaluation and Research

Feb. 16-18, Gaithersburg, Md.

JOINT MEETING OF THE ARTHRITIS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE (FDA)

Committees to discuss overall benefit to risk considerations, including cardiovascular and gastrointestinal safety concerns, for COX-2 selective nonsteroidal anti-inflammatory drugs and related agents

Feb. 24, Rockville, Md.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss supplemental New Drug Applications S-022, S-024 and S-025 and approved New Drug Application for 20-838, Atacand, of AstraZeneca LP for congestive heart failure in the following ways: S-022, reducing the risk of cardiovascular mortality or heart failure hospitalization when added to an angiotensin-converting enzyme inhibitor-containing regimen in congestive heart failure patients with left ventricular systolic dysfunction; S-024, reducing the risk of cardiovascular mortality or heart failure hospitalization in congestive heart failure patients with left ventricular systolic dysfunction, as a primary renin-angiotensin-aldosterone system modulating treatment; and S-025, reducing the frequency of hospitalizations for heart failure in congestive heart failure patients with preserved left ventricular systolic dysfunction; Atacand is approved for the treatment of hypertension

Feb. 27-28, Boston

2nd ANNUAL VIRAL HEPATITIS DRUG DISCOVERY & DEVELOPMENT SUMMIT

Focuses on research and technologies for hepatitis C and hepatitis B

March 3-4, Gaithersburg, Md.

ONCOLOGIC DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss New Drug Application 21-115 for Combidex from Advanced Magnetics Inc. for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in cancer patients; follow-up to June 2004 FDA workshop on prostate cancer endpoints

March 3-4, Rockville, Md.

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE MEETING (FORMERLY THE BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE) (FDA)

Committee to discuss safety issues related to retroviral vector-mediated tumorigenesis in gene transfer clinical trials

March 11, Gaithersburg, Md.

ANTIVIRAL DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss New Drug Applications 21-797 for entecavir tablets and 21-798 for entecavir oral solution from Bristol-Myers Squibb Co. for chronic hepatitis B infection

March 15, Bethesda, Md.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE (FDA)

Committee to review safety and immunogenicity for two tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed vaccines from GlaxoSmithKline Biologicals and Aventis Pasteur Ltd.

March 16-19, Dallas

ANNUAL SYMPOSIUM OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION

Includes presentation from Nymox Pharmaceutical Corp. on clinical study data for AlzheimAlert, a urine-based diagnostic aid for Alzheimer's disease

March 17, Gaithersburg, Md.

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA)

Committee to discuss and make recommendations on premarket notification submission for use in the induction, maintenance and reversal of mild hypothermia in the treatment of unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest when initial rhythm was ventricular fibrillation

March 17-18, Gaithersburg, Md.

BLOOD PRODUCTS ADVISORY COMMITTEE (FDA)

Committee to hear updates on summary of Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the Transmissible Spongiform Encephalopathies Advisory Committee meeting; update on West Nile Virus guidance; summaries of the Critical Path Initiative workshop; recommendations on the safety of albumin; updates on international agreements and a presentation on sharing information with the public

March 23, Gaithersburg, Md.

NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss microbiologic surrogate endpoints used to demonstrate effectiveness of antiseptic products used in health care settings

March 24, Gaithersburg, Md.

JOINT MEETING OF THE DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss necessary and sufficient safety database to evaluate prescription to over-the-counter switch of topical corticosteroids, particularly for the potential of hypothalamic, pituitary, adrenal and growth suppression

April 26-30, Vienna, Austria

41st ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

Includes presentations on liver transplantation, cirrhosis, tumors and viral hepatitis

May 7-11, San Juan, Puerto Rico

19th INTERNATIONAL CONFERENCE ON ANTIVIRAL RESEARCH

Includes presentations on antiviral drug and antiviral chemotherapy research

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