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FDA Calendar
April 30-May 4, Fort Lauderdale, Fla.
2006 ANNUAL MEETING OF THE ASSOCIATION FOR RESEARCH IN VISION AND OPHTHALMOLOGY
Includes presentation from ISTA Pharmaceuticals Inc. on Xibrom, an anti-inflammatory solution, and Vitrase, a spreading agent for hypodermoclysis; six poster presentations from Inspire Pharmaceuticals Inc. and collaborators
May 1-4, Carlsbad, Calif.
TIDES - OLIGONUCLEOTIDE AND PEPTIDE TECHNOLOGY AND PRODUCT DEVELOPMENT CONFERENCE 2006
Includes presentation from Helix BioMedix Inc. on hexapeptides for bacterial and fungal infections
May 3-4, Rockville, Md.
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE MEETING (FDA)
Committee to review update from Clinical Pharmacology Subcommittee, discuss and provide comments on establishing drug release or dissolution specifications, receive update on activities of Parametric Tolerance Interval Test Workgroup, discuss criteria for establishing a working group for review and assessment of Office of Pharmaceutical Science research programs
May 3-6, San Antonio
AMERICAN PAIN SOCIETY'S 25th ANNUAL SCIENTIFIC MEETING
Includes presentation from DOV Pharmaceutical Inc. on Bicifadine as analgesic in animal models of neuropathic pain and data from phase 3 trial results
May 5, Rockville, Md.
ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)
Committee to discuss New Drug Application 21-824 for Tibotec Therapeutics' Zarnestra (tipifarnib) film-coated tablets for the treatment of elderly patients with newly diagnosed poor-risk acute myeloid leukemia
May 7-11, San Juan, Puerto Rico
19th INTERNATIONAL CONFERENCE ON ANTIVIRAL RESEARCH
Includes presentations on antiviral drug and antiviral chemotherapy research
May 13, Gaithersburg, Md.
ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Committee to hear presentation on FDA's critical path initiative and a presentation from the Office of Surveillance and Biometics in the Center for Devices and Radiological Health
May 14-17, Scottsdale, Ariz.
WOUND HEALING SOCIETY 16th ANNUAL MEETING & EXHIBITION
Includes presentation from Helix BioMedix Inc. on hexapeptides for bacterial and fungal infections
May 15-20, Toronto
ANNUAL MEETING OF THE AMERICAN PSYCHIATRIC ASSOCIATION
Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert, a urine-based diagnostic aid, and its successful clinical studies
May 16-20, New York
AMERICAN SOCIETY OF HYPERTENSION ANNUAL SCIENTIFIC MEETING AND EXPOSITION
Includes presentation from Medicure Inc. on phase 2 Matched study with MC-4232 for cardiovascular and metabolic risk factors
May 17, Gaithersburg, Md.
OBSTETRICS AND GYNECOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Includes presentation from the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health on its responsibility for the review of postmarket study design and discussion, recommendations and vote on a premarket approval application for a spectroscopy-based cervical imaging system for use as an adjunct to colposcopy to enhance the identification of biopsy sites
May 17, Gaithersburg, Md.
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE MEETING (FDA)
Includes discussion on Novartis Pharmaceuticals Corp.'s supplemental New Drug Application 20823, SE1-016, Exelon capsules for mild to moderate dementia associated with Parkinson's disease
May 17-18, Baltimore
INDUSTRY EXCHANGE WORKSHOP ON FOOD AND DRUG ADMINISTRATION CLINICAL TRIAL REQUIREMENTS
Public workshop in cooperation with the Society of Clinical Research Associates on FDA clinical trial statutory and regulatory requirements
May 18-19, Silver Spring, Md.
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE MEETING (FDA)
Includes discussion on risk assessment program marketed drugs, including review and analysis of spontaneous reports of adverse events
May 19, Gaithersburg, Md.
ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETINGS (FDA)
Includes discussion on New Drug Application 21-814, proposed trade name Aptivus (Tipranavir) capsules for Boehringer Ingelheim Pharmaceuticals Inc. for human immunodeficiency virus
May 20, Rockville, Md.
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE MEETING (FDA)
Includes update on individual research programs in the division of therapeutic proteins, center for drug evaluation and research
May 20-25, Los Angeles
DIGESTIVE DISEASE WEEK CONFERENCE
Includes presentation from Callisto Pharmaceuticals Inc. on Guanilib for gastrointestinal inflammation; presentation from Idenix Pharmaceuticals Inc. on Valopicitabine, an nucleoside polymerase inhibitor for hepatitis C and presentation from Cytogen Corp. on Prostascint, a diagnostic imaging agent for newly diagnosed patients with biopsy-proven prostate cancer; presentation on anti-viral activity of ViroPharma Inc. and Wyeth's HCV-796
May 21-25, Orlando, Fla.
106th AMERICAN SOCIETY FOR MICROBIOLOGY ANNUAL GENERAL MEETING
Includes presentation from Helix BioMedix Inc. on hexapeptides for bacterial and fungal infections
May 31-June 3, Scottsdale, Ariz.
20th CONSORTIUM OF MULTIPLE SCLEROSIS CENTERS' ANNUAL MEETING
Includes presentation from PharmaFrontiers Corp. on study of patients treated with monovalent T cell therapy
June 1-5, San Francisco
2006 ANNUAL MEETING OF THE FEDERATION OF CLINICAL IMMUNOLOGY SOCIETIES
Includes presentation from PharmaFrontiers Corp. on proprietary T-cell vaccination technology for autoimmune disease multiple sclerosis
June 2, Atlanta
ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)
Committee to provide advice and recommendations to the agency on FDA's regulatory issues, to discuss Bristol-Myers Squibb Co.'s New Drug Application for Sprycel (dasatinib) tablets for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy
June 2-6, Atlanta
2006 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
Includes presentation from Oncolytics Biotech Inc. on Reolysin clinical trial data, Bioenvision Inc. on Evoltra for adult acute myeloid leukemia; presentation from Cytogen Corp. on Quadramet for multiple myeloma and Cell Genesys Inc. on trial of GM-CSF-gene transduced allogeneic prostate cancer cellular immunotherapy with human anti-CTLA-4 antibody for hormone-refractory prostate cancer and K562/GM-CSF vaccination for tumor burden related to chronic myelogenous leukemia; presentations from ChondroGene Ltd. on use of blood biomarkers to detect colorectal cancer and prostate cancer; presentation from Antisoma plc on phase 2 study of AS1404 for lung cancer and ovarian cancer as well as the phase 1 study of R1550 for breast cancer and presentation from Genitope Corp. on phase 2 clinical trial of MyVax for follicular Non-Hodgkine's Lymphoma
June 21-24, Amsterdam
EUROPEAN LEAGUE AGAINST RHEUMATISM 2006 ANNUAL CONGRESS
Includes presentation from Savient Pharmaceuticals Inc. on phase 2 trial results for Puricase
June 21-23, Toulon, France
14TH INTERNATIONAL SYMPOSIUM ON HIV AND EMERGING INFECTIOUS DISEASES
Includes presentation from Adventrx Pharmaceuticals Inc. on antiviral activity of Thiovir
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 23-27, Chicago
AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY ANNUAL MEETING
Includes presentation for PreMD Inc. on abstract for microwell-based format of LungAlert for lung cancer
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