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Off-Label Promotion Advertising

AdvaMed 2015 Highlights – Part One of Two

by McGuireWoods LLP on

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

by Cooley LLP on

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

by Mintz Levin on

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

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