FDA Calendar

July 22-26, Vienna, Austria

2006 CONTROLLED RELEASE SOCIETY ANNUAL MEETING

Includes presentation from Rigel Pharmaceuticals Inc. on a microencapsulated prodrug to prevent gut hydrolysis and to enhance delivery of drugs to the liver

July 23-27, Chicago

AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY ANNUAL MEETING

Includes presentation by PreMD Inc. on abstract for microwell-based format of LungAlert for lung cancer and BioCurex Inc. on results for Recaf blood test of serum samples from prostate cancer patients and patients with benign prostate lesions

July 26-30, San Diego

AMERICAN ACADEMY OF DERMATOLOGY ANNUAL SUMMER SCIENTIFIC MEETING

Includes presentation from leaders in dermatology and the latest research in the diagnosis and medical, surgical and cosmetic treatment of skin, hair and nail conditions

July 27, Rockville, Md.

THE USE OF BAYESIAN STATISTICS IN MEDICAL DEVICE CLINICAL TRIALS PUBLIC MEETING (FDA)

Meeting to cover the FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials

July 27-28, Tyson's Corner, Va.

2nd ANNUAL OBESITY DRUG DEVELOPMENT SUMMIT

Includes presentation from Manhattan Pharmaceuticals Inc. on oral Oleoyl-estrone for obesity

July 29, Rockville, Md.

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

Committee to hear brief opening remarks and allow time for public participation and comments related to individual FDA research programs during the open public hearing

Aug. 4, Rockville, Md.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-645, proposed trade name MT100 (naproxen sodium and metoclopramide hydrochloride) Tablets from Pozen Inc., for the proposed indication of acute treatment of migraine headache with or without aura

Aug. 9, Gaithersburg, Md.

GENERAL HOSPITAL AND PERSONAL USE DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)

Committee to hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of post market study design, to discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors, including premarket testing recommendations to address this issue

Aug. 25-26, Gaithersburg, Md.

GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)

Committee to hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design and to discuss and make recommendations on the classification of five preamendment medical devices: bone wax, medical maggots, medicinal leeches, tissue expander and wound dressing with a drug

Aug. 29, Gaithersburg, Md.

ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS MEETING (FDA)

Committee to discuss New Drug Application 21-945 for Gestiva 17 alpha-hydroxyprogesterone caproate injection from Adeza Biomedical for the prevention of preterm delivery in women with a history of prior preterm delivery

Sept. 2-6, Barcelona, Spain

WORLD CONGRESS OF CARDIOLOGY 2006

Includes presentation from Vasogen Inc. on phase 3 Acclaim trial of Celacade technology in advanced chronic heart failure

Sept. 3-8, Sydney, Australia

10th INTERNATIONAL CONGRESS ON OBESITY

Includes presentation from Manhattan Pharmaceuticals Inc. on long-term treatment of zucker obese rats with Oleoyl-estrone to decrease expression of pro-inflammation markers in white adipose tissue

Sept. 6, Rockville, Md.

ARTHRITIS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss Biologics License Application 125118/0, proposed trade name Orencia (abatacept) from Bristol Myers Squibb, proposed indication for the treatment of moderately to severely active rheumatoid arthritis

Sept. 7-8, Gaithersburg, Md.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-999 for paliperidone extended-release tablets from Janssen, LP and Johnson & Johnson Pharmaceutical Research and Development, LLC for schizophrenia as well as the New Drug Application 21-992 for desvenlafaxine succinate ER tablets from Wyeth Pharmaceuticals for major depressive disorder

Sept. 8-9, Silver Spring, Md.

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-868, proposed trade name Exubera (insulin recombinant deoxyribonucleic acid origin powder for oral inhalation), 1 mg and 3 mg powder for inhalation from Pfizer Inc., for the treatment of adult patients with diabetes mellitus, and committee to discuss New Drug Application 21-865, proposed trade name Pargluva (muraglitazar) Tablets, 2.5 mg and 5 mg from Bristol-Myers Squibb, for the treatment of type 2 diabetes mellitus

Sept. 8-9, Gaithersburg, Md.

ORTHOPEDIC AND REHABILITATION DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)

Committee to hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design; update on the status of recent devices brought before the committee; committee to discuss, make recommendations and vote on a premarket approval application for a hip joint metal/metal semi constrained resurfacing hybrid prosthesis (cemented femoral component), a device intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes; committee to discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain

Sept. 10-13, Seattle

10th ANNUAL SCIENTIFIC MEETING OF THE HEART FAILURE SOCIETY OF AMERICA

Includes presentation from Vasogen Inc. on results from its Acclaim trial for Celacade technology in advanced chronic heart failure

Sept. 10-14, Edinburgh, Scotland

INTERNATIONAL CONGRESS OF CLINICAL NEUROPHYSIOLOGY

Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert, a urine-based diagnostic aid

Sept. 11-12, Gaithersburg, Md.

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-931 for garenoxacin mesylate tablets and NDA 21-932 for intravenous garenoxacin mesylate tablets under the proposed trade name Geninax from Schering Corp. for the treatment of acute bacterial exacerbation of chronic bronchitis

Sept. 13-14, Bethesda, Md.

ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-491, proposed trade name Xinlay (atrasentan hydrochloride) Capsules from Abbott Laboratories, proposed indication for the treatment of men with metastatic hormone-refractory prostate cancer; NDA 21-743, S003 for Tarceva (erlotinib) Tablets from OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metastatic pancreatic cancer; NDA 21-880, proposed trade name Revlimid (lenalidomide) from Celgene Corp., proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; and NDA 21-877, proposed trade name Arranon (nelarabine) Injection from GlaxoSmithKline, proposed indication for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, at least two chemotherapy regimens

Sept. 14-17, Copenhagen, Denmark

42nd EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES CONFERENCE

Includes presentation from CeNeS Pharmaceuticals plc on CNS 5161, a neuronal glutamate receptor antagonist

Sept. 14-17, Copenhagen, Denmark

2006 GORDON RESEARCH CONFERENCE ON CHEMOTACTIC CYTOKINES

Includes presentation from Chemokine Therapeutics on compound CTCE-0324 to treat blood vessel regeneration

Sept. 14-18, Beijing

7th INTERNATIONAL CONFERENCE OF THE ASIAN CLINICAL ONCOLOGY SOCIETY

Includes presentation from Adventrx Pharmaceuticals Inc. on CoFactor and its EFT antitumor effect against human colorectal HT-29 tumor xenografts in nude mice

Sept. 22, Bethesda, Md.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING (FDA)

During teleconference meeting, committee will hear an overview of the research of the Laboratory of Retroviruses and the Laboratory of Immunoregulation, Division of Viral Products, and the Laboratory of Respiratory and Special Pathogens and the Laboratory of Methods Development and Quality Control, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, and in closed session will discuss the reports from the Laboratory Site Visits of April 18 and 19, 2005 and June 16, 2005

Oct. 4, Gaithersburg, Md.

JOINT MEETING OF THE ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE AND THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE MEETING (FDA)

Committee to discuss the administration's efforts to assess the product quality of currently marketed levothyroxine sodium drug products

Oct. 14-18, Chicago

AMERICAN SOCIETY FOR ANESTHESIOLOGY MEETING

Includes presentation from CeNeS Pharmaceuticals plc on short-acting sedative CNS 7056X for use in the induction and maintenance of anesthesia

Oct. 18-20, Vienna, Austria

SECOND INTERNATIONAL CONFERENCE ON INFLUENZA VACCINES FOR THE WORLD 2006 MEETING

Includes presentation from Carrington Laboratories Inc. on an inactivated influenza nasal powder vaccine, GelVac

Dec. 9-12, Orlando, Fla.

ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY

Includes presentation from Sunesis Pharmaceuticals Inc. from a phase 1 clinical trial of its lead small molecule drug SNS-595 for treatment of patients with refractory acute leukemias

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