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 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

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. 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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