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Precision Medicine: Challenging the Regulatory Landscape
“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge.
Kupchyk Esq., former Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation, reveals what FDA insiders are thinking as they confront this challenge to traditional regulatory structures … and how they plan to move forward.
Over the course of 90 fast-paced minutes, Ms. Kupchyk, now a top member of the Washington FDA bar, will cover:
Should you cash in on the precision medicine bonanza? By all means. Should you take appropriate regulatory precautions beforehand? But of course. This is the quick, easy, reliable way to do so.
Drug and device makers whose products could be considered components of personalized medicine. Specific job titles include:
Areta Kupchyk Esq., Partner, Foley Hoag LLP, is a former FDA official who now advises drug, device and biotech companies, as well as healthcare providers and institutions, researchers, and investors. She co-chairs Foley Hoag’s Food and Drug Law Practice group in the firm's Washington, D.C. office. Ms. Kupchyk draws upon almost 10 years of experience as FDA Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation to provide nuanced counsel on current agency views for meeting pre- and post-approval requirements.
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