The approval process... pre-approval concerns... product labeling... clinical trials... adverse events reports... patent concerns... exclusivity - all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation.
Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices - but who do deal with FDA regulated products - to have a familiarity with these concepts. The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this field to have a clear understanding of the dynamics of the FDA.
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