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- Feed Preview | Life Sciences Legal Update
FDA finalizes guidance on voluntary recalls, issues recommendations for industry
The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how...
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 ...
Reed Smith Attorneys to Present AdvaMed Webinar on “Top 10 Product Liability Issues”
Michael Brown and Lisa Baird from our Life Sciences Health Industry Team will be presenting an hour-long AdvaMed Medical Technology Learning Institute webinar on “Top 10 Product Liability Issue...
French Supreme Court Ruling Clarifies Liability For Defective Products
A February 25, 2016, decision by the French Supreme Court clarifies some conditions for the imposition of liability with respect to defective products in ways that may be surprising to those more...
Drug and Device Law Blog Has Moved – Sign Up for New E-mailed Posts
Five of our Reed Smith life sciences team members – Jim Beck, Steve McConnell, Eric Alexander, Steven Boranian and Rachel Weil – blog on pharmaceutical and medical device product liability ne...
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...
Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary
This post was first published on the Drug and Device Law Blog. We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that ...
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....