FDA Calendar

Aug. 13-18, Toronto

AIDS 2006 - XVI INTERNATIONAL AIDS CONFERENCE

Includes presentation from Aethlon Medical Inc. on human safety data of its Hemopurifier, a therapeutic device targeted to treat drug and vaccine resistant pathogens; presentation on Aug. 17 from Panacos Pharmaceuticals, Inc. on fusion inhibitor program; presentation on Aug. 17 from Ambrilia Biopharma Inc. on protease inhibitor PPL-100.

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. 25-27, New York

5th INTERNATIONAL CONGRESS ON TARGETED THERAPIES IN CANCER

Includes presentation from Ariad Pharmaceuticals Inc.

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 and presentation from Encysive Pharmaceuticals on Thelin (sitaxsentan sodium)

Sept. 2-6, Munich, Germany

EUROPEAN RESPIRATORY SOCIETY 16th ANNUAL CONGRESS

Includes presentation from Encysive Pharmaceuticals on Thelin (sitaxsentan sodium)

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, Silver Spring, Md.

ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application NDA 21-874, proposed trade name Genasense 2 (oblimersen sodium) Injection from Genta Inc., proposed indication for the treatment of patients with chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide; NDA 020-287, Fragmin (dalteparin sodium) from Pfizer Inc., proposed indication for the extended treatment of symptomatic venous thromboembolism, proximal deep vein thrombosis, and/or pulmonary embolism to reduce the recurrence of VTE in patients with cancer; and NDA 21-660, Abraxanne (paclitaxel protein-bound particles for injectible suspension) (albumin-bound) from Abraxis Bioscience Inc., including trial design issues for adjuvant treatment of node-positive breast cancer

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. 7-8, Dublin, Ireland

BRITISH ASSOCIATION FOR THE STUDY OF THE LIVER'S 2006 MEETING

Includes presentation from Bioenvision for its abstract on Suvus and its phase 2 study focused on chronic hepatitis C and refractory hepatitis C

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. 10-11, Sendai, Japan

TETRAHYDROBIOPTERIN AND ALTERNATIVE TREATMENTS FOR PHENYLKETONURIA, CARDIOVASCULAR DISEASES AND DIABETES SATELLITE MEETING TO THE 2006 INTERNATIONAL CONGRESS ON INBORN ERRORS OF METABOLISM

Includes presentation from BioMarin Pharmaceutical Inc. on clinical-stage programs for Phenoptin (sapropterin dihydrochloride) for the treatment of phenylketonuria and 6R-BH4 for the treatment of cardiovascular indication

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. 12-16, Chiba, Japan

10th INTERNATIONAL CONGRESS OF INBORN ERRORS OF METABOLISM

Includes presentation from BioMarin Pharmaceutical Inc. on clinical-stage programs for Phenoptin (sapropterin dihydrochloride) for the treatment of phenylketonuria and 6R-BH4 for the treatment of cardiovascular indication

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. 21, Rockville, Md.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss clinical data for aprotinin injection, trade name Trasyol, the approved product from Bayer Pharmaceuticals' New Drug Application 020-304, to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass

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

Sept. 26-27, Gaithersburg, Md.

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss regulatory and nonregulatory mechanisms to enhance mammography quality while reducing the regulatory and inspection burden on facilities; recommendations made by the Institute of Medicine regarding the current Mammography Quality Standards Act program, interventional mammography, and non-mammographic breast imaging procedures; and all guidance documents issued since the last meeting

Sept. 27, Gaithersburg, Md.

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

Committee to hear a presentation on FDA's Critical Path Initiative and discuss and make recommendations regarding general issues related to the model used for validation testing to support a claim of decontamination of potentially transmissible spongiform encephalopathy contaminated surgical instruments

Sept. 27-30, San Francisco

INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Includes presentation from Ceragenix Pharmaceuticals Inc. on nine research abstracts on Ceragenins, synthetically produced small molecule chemical compounds comprised of a sterol backbone with amino acids and other chemical groups

Sept. 29, Bethesda, Md.

RESEARCH REVIEW SUBCOMMITTEE OF THE CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE MEETING (FDA)

Subcommittee to listen to presentations about the research program at the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research , which is intended to provide dynamic, responsive, cutting edge research to contribute to the office's regulatory mission and facilitate development of safe and effective biological products

Sept. 29, Rockville, Md.

BLOOD PRODUCTS ADVISORY COMMITTEE MEETING (FDA)

Committee to discuss New Drug Application 21-882, proposed trade name Exjade (deferasirox) Tablets for Oral Suspension from Novartis Pharmaceutical Corp., proposed for the indication of the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis); committee to hear an overview of the research programs in the Laboratory of Hemostasis and the Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, CBER, and in closed session will discuss the report from the laboratory site visit of Feb. 25, 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. 9-13, New Orleans

56th ANNUAL MEETING OF THE AMERICAN SOCIETY OF HUMAN GENETICS

Includes presentation from BioMarin Pharmaceutical Inc. on clinical-stage programs for Phenoptin (sapropterin dihydrochloride) for the treatment of phenylketonuria and 6R-BH4 for the treatment of cardiovascular indication

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. 16-17, Boston

4th ANNUAL SYMPOSIUM ON ANTI-ANGIOGENESIS: NEW FRONTIERS IN THERAPEUTIC DEVELOPMENT

Includes presentation from Ariad Pharmaceuticals Inc.

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

Oct. 27-31, Boston

THE LIVER MEETING, 57th ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES

Includes presentation on Oct. 30 from Peregrine Pharmaceuticals, Inc. on phase 1a study of bavituximab

Nov. 2-4, Venice, Italy

12th ANNUAL CONNECTIVE TISSUE ONCOLOGY SOCIETY MEETING

Includes presentation from Ariad Pharmaceuticals Inc.

Nov. 7-10, Prague, Czech Republic

18th EORTC-NCI-AACR (ANE) SYMPOSIUM ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

Includes presentation from Ariad Pharmaceuticals Inc.

Nov. 11-14, Las Vegas

MEETING OF THE AMERICAN ACADEMY OF OPHTHALMOLOGY

Includes presentation from InSite Vision Inc. on second trial of the topical eye drop antibiotic AzaSite

Dec. 9-12, Orlando, Fla.

ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY

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

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