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Inducements Food and Drug Administration (FDA)

Rothwell, Figg, Ernst & Manbeck, P.C.

Just Skinny Enough: District Court Dismisses Inducement Claims Against Generic “Skinny Label”

On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label”...more

Baker Donelson

Taking Pills for Pay: FDA Releases Information Sheet on Paying Research Subjects

Baker Donelson on

In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

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