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


Drug Development

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…
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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…
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Biosimilars


Citizen Petitions and Litigation

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…
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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…
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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…
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Advertising and Promotion


FDA Policy


Corporate Support
