FDA Calendar

July 15-18, Glasgow, Scotland

43rd EUROPEAN RENAL ASSOCIATION-EUROPEAN DIALYSIS AND TRANSPLANT ASSOCIATION CONGRESS

Includes presentation from Roche on four abstracts for its anti-anemia drug, CERA or Continuous Erythropoietin Receptor Activator, and the phase 3 clinical program

July 16-20, Madrid, Spain

10th INTERNATIONAL CONFERENCE ON ALZHEIMER'S DISEASE

Includes presentation from Predix Pharmaceuticals on studies with PRX-03140, a proprietary serotonin 4 5-HT4 receptor agonist being developed for Alzheimer's disease; PRX-08066, a proprietary 5-HT2B receptor antagonist being developed for the treatment of pulmonary hypertension and hypertension associated with chronic obstructive pulmonary disease; and PRX-07034, a proprietary 5-HT6 receptor antagonist being developed for the treatment of obesity and also for cognitive impairment

July 19-21, Banff, Alta.

PEDIATRIC ONCOLOGY EXPERIMENTAL THERAPEUTICS INVESTIGATION CONSORTIUM CONFERENCE

Includes presentation from Med BioGene Inc. on molecular-based diagnostic micro arrays

July 21, Gaithersburg, Md.

BLOOD PRODUCTS ADVISORY COMMITTEE MEETING (FDA)

Committee to hear updates on the summary of the May 2005 meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; disseminated intravascular coagulation associated with acute hemoglobinemia following anti-D Immune Globulin Intravenous administration for idiopathic thrombocytopenic purpura; update on safety of albumin; summary of June 2005 workshop on Biological Therapeutics for Rare Plasma Protein Disorders; summary of July 2005 workshop on Leukoreduction and updates on West Nile Virus guidance as well as discussion on the management of donors and units that test positive for hepatitis B virus DNA by nucleic acid tests and the scientific basis for review of Varicella Zoster Immune Globulin and Dextran 1 pre-treatment for safe use of Dextran 40/70

July 22, Gaithersburg, Md.

RESEARCH REVIEW SUBCOMMITTEE OF THE BLOOD PRODUCTS ADVISORY COMMITTEE MEETING (FDA)

Subcommittee to listen to presentations to further a dynamic, responsive and cutting edge research program in the Office of Blood Research and Review, Center for Biologics Evaluation and Research, that facilitates development of safe and effective biological products

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

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

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. 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. 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

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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