August 5th, 2019
Lassman Law+Policy was privileged to represent Braeburn, Inc. (with co-counsel Goodwin) in securing this U.S. District Court ruling overturning an FDA decision on 3-year exclusivity as unreasonable and arbitrary and capricious. The decision, issued on July 22, 2019, orders FDA to reconsider "with deliberate speed" Braeburn's application for approval of an innovative new injectable treatment for opioid use disorder. Read all about it here.
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Scott Lassman
Scott Lassman has more than 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice. He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters...
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