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Biotechnology Calendar
June 26-30
DRUG INFORMATION ASSOCIATION 41st ANNUAL MEETING
Discuss regulatory and public policy environment pertaining to pharmaceuticals with FDA emphasis
June 28
PEDIATRIC ETHICS SUBCOMMITTEE OF THE PEDIATRIC ADVISORY COMMITTEE
Discuss Institutional Review Board referral of proposed clinical investigation involving both FDA-related product and research with children as subjects
June 29
PEDIATRIC ADVISORY COMMITTEE
Discuss Institutional Review Board referral of proposed clinical investigation involving both FDA-related product and research with children as subjects; report by agency on Adverse Event Reporting for methylphendidate
July 13-14
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE (FDA)
Implications of recent data on safety of long-acting beta-agonist bronchodilators; need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease under 21 CFR 2.125
July 13-15
FOOD ADVISORY COMMITTEE (FDA)
Evaluate the Center for Food Safety and Applied Nutrition Threshold Working Group draft report "Approaches to Establish Thresholds for Major Food Allergens and Gluten; draft report's approaches for gluten thresholds; determination if report is scientifically sound in its analyses and approaches based on charge and questions from FDA
Sept. 12-14
PDA/FDA JOINT REGULATORY CONFERENCE - THE PRODUCT LIFE CYCLE: QUALITY BY DESIGN, IMPLEMENTATION AND CONTINUOUS IMPROVEMENT
Collaboration, education and networking between FDA, pharmaceutical and biopharmaceutical industries
Sept. 21-23
2005 BIO MID-AMERICA VENTUREFORUM
Showcase of biotech and medical device product and platform companies
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