Joy Liu

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Professional Experience

: Current; Joy provides legal and strategic advice to pioneer pharmaceutical and biotechnology companies on a broad range of regulatory issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She has counseled clients on life cycle management issues, including orphan, pediatric, and Hatch-Waxman exclusivity matters, over-the-counter switches, and compliance issues related to drug sampling. Joy has prepared citizen petitions on approval requirements for generic versions of discontinued formulations of products and locally acting products, among others. She also provides regulatory assistance on securities disclosures for publicly traded companies and on corporate transactional matters, such as drug company acquisitions. Joy has particular expertise concerning the advertising and promotion of pharmaceuticals and biological products. She has served as in-house counsel for a large pharmaceutical company, advising the sales and marketing staff of a $3 billion product on a variety of promotional issues, including those arising under the Anti-Kickback Statute and the False Claims Act. Joy has also served as the legal representative on promotional review committees of emerging companies with single products.

Education