Practice Areas

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Lassman Law+Policy handles all FDA regulatory issues but has special expertise in the following areas:

Exclusivity (see the firm’s Exclusivity Rules blog)
Drug Development, including 505(b)(2) applications and dispute resolution
Biosimilars
Citizen Petitions and Litigation
FDA Policy, including proposed legislation, regulations, and guidance documents
Advertising and Promotion
Corporate Support, including regulatory due diligence

For additional information, you are invited to contact the firm.

Exclusivity

Pharmaceutical and biological products are subject to a dizzying array of exclusivity and patent certification provisions. Because these provisions determine whether a product can be approved — and when — it is critical for companies to thoroughl… Read More

Drug Development

Obtaining FDA approval of a medical product is not always straightforward. The process can be derailed by a multitude of problems, including scientific disagreements, new or evolving regulatory requirements, labeling negotiations, and unexpected pate… Read More

505(b)(2) Applications

Prior to 1999, 505(b)(2) applications were rarely used and little understood. Since then, 505(b)(2) submissions have skyrocketed and now comprise 50% or more of all New Drug Applications filed with the Food and Drug Administration (FDA) each year. Th… Read More

Dispute Resolution

During the FDA approval process, companies often hit roadblocks with FDA. These can be caused by scientific disagreements, new or evolving regulatory requirements, or even unexpected patent certification or exclusivity issues. Unless resolved quickly… Read More

Biosimilars

The Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for certain copycat versions of biological products, known as “biosimilars” and “interchangeable biological products.” Since BPCIA’s enac… Read More

Citizen Petitions and Litigation

Over his nearly 30 years of experience as an FDA regulatory attorney, Scott Lassman has strong record of success using both the Citizen Petition process and, when necessary, litigation with FDA under the Administrative Procedure Act (APA) to achieve… Read More

Citizen Petitions

Citizen Petitions have become the subject of significant criticism recently, but they are nothing more than a public process for asking FDA to take – or refrain from taking – virtually any type of regulatory action. As such, they are valuable and… Read More

APA Litigation

Sometimes, litigation is inevitable. Either it is the last and best option to challenge an incorrect FDA decision, or it is a competitor’s last and best option. In either case, a company may decide it makes sense to bring an APA lawsuit against FDA… Read More

Expert Opinion

Litigation is an unfortunate fact of life for many life sciences companies as well as those who invest in such companies. Commercial disputes can arise with partners, collaborators, contractors, competitors, investors, and insurers. Oftentimes, such… Read More

Advertising and Promotion

FDA’s rules governing the advertising and promotion of medical products are complex. Sometimes, the review of promotional material may seem to be more art than science. But the repercussions for getting it wrong can be severe – and not just from… Read More

FDA Policy

FDA’s regulatory decisions are not always based exclusively on facts or science. Often, they are driven in whole or in part by larger policy considerations. For example, FDA often considers what type of precedent its decision will create, how its d… Read More

Corporate Support

Lassman Law+Policy provides comprehensive support on FDA regulatory law to clients working on a variety of corporate transactions. Many large law firms with leading corporate practices do not have the type of specialized expertise in FDA regulatory l… Read More

Scott Lassman

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...