This article was originally published in The Gray Sheet
Executive SummaryFDA approves investigational device exemption to study firm's LiquiBand topical wound closure glue in trial of 600 patients at 20 centers. Clinical endpoints include cosmesis and evidence of dehiscence, or wound opening, over a 90-day follow-up period. Based on the company's proprietary n-butyl cryanoacrylate technology, LiquiBand is intended to substitute for sutures and staples in surgical operations, "or other traditional closures in the treatment of external cuts and wounds," the company's June 15 release notes. MedLogic's proposal for a modular PMA submission also receives a nod from the agency
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.