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St. Petersburg, FL5/6/2015
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An analysis of the impact of FDA’s four expedited programs on
development and review of drugs for serious conditions over the last two-and-a-half
years since breakthrough therapy designation was introduced, including a
Patients and their advocates appear to be getting more prominent attention from the US Food and Drug Administration (FDA) if a recent release of documents in advance of an upcoming advisory committee meeting is any indication.
Linda Lin, vice president of international business for Shanghai MicroPort Medical (Group) Co. Ltd., and a member of RAPS’ China Advisory Council, offers her opinions on the regulatory profession and shares lessons from her experience for young Chinese men and women who may wish to pursue a regulatory career.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.