New drugs that are brought to market in the US must face the FDA approval process, which frequently includes a public discussion or advisory committee meeting. With an extraordinary knowledge of drug approval and fresh from his experience on the FDA advisory committee that examined dronedarone, Dr Sanjay Kaul joins the show to address:
How a drug moves from the realm of research to clinical practice.
The role of the FDA in the approval process.
How the FDA influences clinical research and the way research is reported.
The thorny issue of industry-academic relationships.
See:
ATHENA scrutinized in media: Questions raised about access to raw data and clinical end points
Avandia and FDA both subject of severe criticism at Congressional hearing
Experts hash over new review challenging dronedarone's value in AF
FDA approves dronedarone for atrial fibrillation
What are your thoughts on FDA advisory committee meetings and the drug-approval process? Join in the discussion by commenting below.
Cite this: Episode #23: FDA advisory committee meetings and the drug-approval process with Dr Sanjay Kaul - Medscape - Jun 30, 2010.
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