Deep Expertise for the Most Complex FDA Problems

Lassman Law+Policy

Lassman Law+Policy is a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems. The firm works with sophisticated pharmaceutical, biotechnology, and medical device companies as well as investors and industry trade associations. Whether it is a cutting-edge exclusivity issue, a stalled approval program, or a biosimilar policy initiative, Lassman Law+Policy has the expertise and experience to resolve it. Scott Lassman is a recognized expert with nearly thirty years of experience in FDA law. In 2018, he was named one of the top five FDA regulatory attorneys in the United States.
Scott’s experience helps clients navigate the many legal gray areas they face, avoiding unseen dangers and taking advantage of hidden opportunities. Scott doesn’t just know the law, he knows the FDA — how it operates and how it interprets and enforces the law. Scott also is attuned to the special needs of corporate clients because he’s been one himself. In addition to his many years in private practice, Scott has worked in-house at both a mid-size drug company and a national trade association representing the innovative pharmaceutical industry. Because of this valuable experience, Scott seeks to provide practical solutions to his clients that focus, first and foremost, on achieving their business objectives. And he seeks to do so efficiently and on time.

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Scott Lassman has nearly 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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Recent Exclusivity Rules Posts

On July 22, 2019, the United States District Court for the District of Columbia ruled against the Food and Drug Administration (“FDA”) in a lawsuit challenging FDA’s application of 3-year exclusivity in the context of a 505(b)(2) application. T… Read More
In the world of exclusivity, there is one overarching rule: all good things must come to an end. New chemical entity (NCE) exclusivity expires after five years (sometimes four); orphan drug exclusivity ends after seven years; and even Reference Produ… Read More
Last week, the Food and Drug Administration (FDA) finalized its guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application. The final guidance provides useful tips on the differences between ANDAs and 505(b)(2) applications and the… Read More

Read More Recent Exclusivity Rules Posts