Video Link: https://www.youtube.com/watch?v=Id5KVzABDpM

Brian Malkin discusses some differences in orphan drug regulations in us vs europe
Brian J. Malkin is a partner in the Washington, DC office of Frommer Lawrence Haug LLP. Mr. Malkin worked as a regulatory counsel at the US Food and Drug Administration in both the Center for Drug Evaluation and Research and the Office of the Commissioner, specializing in the areas of intellectual property and exclusivity related to the Hatch-Waxman Act, new product evaluations, and compliance issues related to clinical investigations. In private practice, Mr. Malkin works with pharmaceutical and biotechnology companies to develop strategies regarding regulatory requirements and clinical development plans. Mr. Malkin has a bachelor #39;s degree in biochemistry from the University of Maryland, and a JD from George Washington University. Brian is also editor and contributor to http://www.fdalawyersblog.com, an excellent blog on the inner workings of the regulatory process.From:rarediseasereport2Views:1 0ratingsTime:00:59More inPeople Blogs

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Brian Malkin discusses some differences in orphan drug regulations in us vs europe - Video