U.S./EU DEVICE MRA AGREEMENT IN PRINCIPLE SETS JAN. 31 DEADLINE FOR PACT;FDA TO OPPOSE INCLUSION OF PRODUCT APPROVALS AT TALKS IN BRUSSELS
This article was originally published in The Gray Sheet
Executive SummaryFDA's opposition to the inclusion of product approvals in a device mutual recognition agreement with Europe for likely will be the focus of discussion at a U.S. government/industry meeting planned for the next few weeks. Industry and government reps from FDA, the Department of Commerce and the U.S. Trade Representative's office are meeting to discuss the U.S. position on a device MRA in preparation for January U.S./European Union trade talks in Brussels.
You may also be interested in...
According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.
HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More
GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.
In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.