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FDA Calendar
July 11, Rio Grande, Puerto Rico
ANNUAL MEETING OF THE AMERICAN SOCIETY FOR PHOTOBIOLOGY
Includes presentation from Provectus Pharmaceuticals on its topical drug Xantryl for infections caused by highly dangerous antibiotic resistant bacteria
July 9-13, Chicago
25th BIENNIAL CONGRESS OF THE COLLEGIUM INTERNATIONALE NEURO-PSYCHOPHARMOCOLOGICUM
Includes presentation from DOV Pharmaceutical Inc. on phase 3 trial of bicifadine in patients with chronic low back pain
July 12-15, Washington
13th WORLD CONFERENCE ON TOBACCO OR HEALTH
Includes presentation from Nymox Pharmaceutical Corp. on results for saliva NicAlert test for tobacco exposure
July 13-14, Gaithersburg, Md.
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE MEETING (FDA)
Includes discussion on the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators and the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease
July 13-15, Greenbelt, Md.
FOOD ADVISORY COMMITTEE MEETING (FDA)
Includes evaluation on the CFSAN Threshold Working Group draft report "Approaches to Establish Thresholds for Major Food Allergens and Gluten" as well as discussion on the draft report's approaches for food allergen thresholds and gluten thresholds
July 15, Gaithersburg, Md.
IMMUNOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Committee to hear 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; to discuss, make recommendations and vote on a premarket approval application for a laboratory assay designed to measure levels of neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer's disease
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 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. 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
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