Biotechnology Calendar

June 22 and 23

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA)

Premarket approval application for a cardiac device intended to treat patients with heart failure; humanitarian device exemption for an artificial heart

June 23

OBSTETRICS AND GYNECOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

Presentation on the FDA Critical Path Initiative and premarket approval application for fetal heart monitoring devices

June 26-30

DRUG INFORMATION ASSOCIATION 41st ANNUAL MEETING

Discuss regulatory and public policy environment pertaining to pharmaceuticals with FDA emphasis

June 28

PEDICATRIC 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 and 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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