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

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

Exclusivity

Exclusivity

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 thoroug… Read More
Drug Development

Drug Development

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 pa… 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.… 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 qui… Read More
Biosimilars

Biosimilars

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 en… Read More
Citizen Petitions and Litigation

Citizen Petitions and Litigation

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 a… 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… 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, suc… Read More
Advertising and Promotion

Advertising and Promotion

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 fro… Read More
FDA Policy

FDA Policy

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… Read More
Corporate Support

Corporate Support

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… Read More
Cannabis

Cannabis

Cannabis The regulatory landscape governing cannabis and cannabinoids is changing rapidly, both at the federal and state level. From the de-scheduling of hemp, to FDA’s reconsideration of its policies regarding cannabidiol (CBD) in food and dietary suppleme… Read More