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FDCA
242 published works
Drug & Device Law
SG’s Latest Brief On Implied FDCA Preemption Under Buckman
By Bexis
On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena…
Drug & Device Law
Going The Distance To Limit Preemption
Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of…
Drug & Device Law
Monday’s Recommended Reading — Back to first principles: a new model for the regulation of drug promotion
Friction between the First Amendment and the FDA’s attempts to regulate off-label drug promotion has existed for decades. It has sparked an ever growing body of case law that often finds…
Drug & Device Law
Breaking News − Reinforcement For Buckman
By Bexis
We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 1419423 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in…
Drug & Device Law
400 Pages of Proposed FDCA Amendments – What Might Help Us?
We wanted to draw your attention to a draft bill recently released by House Republicans, proposing amendments and overhauls of numerous FDCA provisions. It is a monster – 400 pages long –…
Drug & Device Law
Ninth Circuit Swings and Misses with Buckman Preemption
Because we hail from San Francisco, we sometimes feel a certain hometown pride in the Ninth Circuit, whose San Francisco home is one of the most beautiful public buildings in the United…
Marler Blog
Botulism and Listeria Risks Force Closure of Neptune Manufacturing
By Bill Marler
Neptune Manufacturing agreed to a permanent injunction amid claims that it did not ensure a safe environment for seafood production. The Order prohibits Neptune from committing violations of the federal…
Drug & Device Law
When More Is Neither Better Nor a Lawsuit
This post is from the non-RS side of the blog only. I didn’t know that the SPF value for sunscreens can reach higher than 100. But they can. As someone of…
Drug & Device Law
Third Circuit: “Safe and Effective” Isn’t an Express Warranty
By Bexis
Express warranty is one of those claims that is often raised in prescription medical product liability actions, but seldom pursued with any intensity. A lot of express warranty claims drop out right away…
Antitrust Law Blog
Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals
Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food,…