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About
Provided by Peter O Safir
Career
Peter Safir has been practicing in the food and drug field for over 25 years. He regularly represents pharmaceutical and biotechnology companies on all aspects of regulation, including drug/biologic development and approval, marketing, manufacturing, and compliance issues. He has litigated many cases protecting data exclusivity for pioneer products and structured numerous patent settlements between research based companies and ANDA applicants. He has advised companies on promotional practices; GMP compliance and with respect to Anti-Kickback statutes; and defended companies and individuals in FDA and DOJ criminal and civil enforcement proceedings.
Personal
B.A. Princeton University 1967; J.D. Yale Law School 1972; Professorial Lecturer in Food and Drug Law at George Washington University Law School 1991-2020.
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