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- Feed Preview | Life Sciences Legal Update
Off-Label Promotion And The First Amendment Updates
Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free ...
A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order
We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against...
UPDATE: Pacira Pharmaceutical Inc. v. FDA Lawsuit Settled
The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled. Pacira will be receiving essentially eve...
Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues
As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its...
Change Coming to FDA’s “Intended Use” Regulations?
Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R....
First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA
The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated produc...
What Comes Next In Amarin Pharm v. FDA?
The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” sta...
Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues
In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement a...
Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment
Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug...
FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit
As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding t...