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 patent certification or exclusivity issues. If not properly anticipated or addressed, these problems can delay or prevent approval of drugs, biologics, biosimilars, combination products, and medical devices.

Lassman Law+Policy helps companies avoid these problems before they arise and overcome them when they do.

505(b)(2) Applications

Scott Lassman has particular experience helping companies develop drug products via the 505(b)(2) approval pathway. 505(b)(2) applications are particularly attractive for companies developing innovative products based on known active ingredients because they allow streamlined development programs. However, 505(b)(2) applications also entail unique risks — such as “submarine exclusivity” — that need to be considered and addressed. Scott has helped many companies successfully navigate the opportunities and risks presented by 505(b)(2) applications. More on 505(b)(2) applications.

FDA Dispute Resolution

Scott also has deep experience utilizing FDA’s dispute resolution procedures to get stalled development programs back on track. He has helped companies resolve disputes with FDA in the context of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) applications, Biologic License Applications (BLAs), and section 351(k) biosimilar applications (aBLAs). He has experience with both formal and informal dispute resolution as well as with requests to the various center Ombudsmen. More on FDA dispute resolution.

Labeling Assessment

In addition, Scott helps companies assess proposed labeling and labeling “carve-outs” to ensure they satisfy applicable regulatory requirements while avoiding patent or exclusivity problems. These issues are particularly relevant to generic drug applications (ANDAs) and 505(b)(2) applications. However, Scott has found that labeling reviews are also important for biosimilar applications (aBLAs) where labeling issues and “carve-outs” are especially complex since, unlike generic drugs, there is no “same labeling” requirement for biosimilars.

You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy in drug development matters.

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