FDA News
FDA Agrees to UltraShape 510(k) Pathway – Expected to Shorten FDA Clearance Process
UltraShape Ltd. announced today that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised. Proceeding under the 510(k) pathway is expected to simplify and shorten the submission […]
FDA approves adapalene lotion for acne
The Food and Drug Administration (FDA) has approved the lotion formulation of adapalene (Differin 0.1 percent, Galderma) for the topical treatment of acne in patients age 12 and older, Medscape Today reports.FDA approval was based on data from two 12-week, multicenter clinical trials of 2,141 patients with 20 to 50 inflammatory and 30 to 100 […]
FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure
The U.S. Food and Drug Administration issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products. The U.S. companies involved have made claims […]
Mesa firm gets FDA approval on ultrasound device
A Mesa startup company has developed a medical device that uses ultrasound technology to treat everything from sagging eyebrows to liver cancer. Guided Therapy Systems of Mesa said the device allows doctors to see and treat tissue without using traditional surgery. The device will be used initially for cosmetic purposes, but backers say the technology […]
Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System
Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized […]
Pharma bracing for tougher FDA guidance on trials
Transparency welcomed, but threat of added costs creates concerns. Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials. And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions […]
Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
BURLINGTON, Mass., Oct. 16 /PRNewswire-FirstCall/ — Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced the termination of its agreement with Johnson & Johnson Consumer Companies Inc (“JJCC”), a Johnson & Johnson company, to develop, clinically test and commercialize home-use, light-based devices for (i) reducing […]
Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses
The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process. Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that […]
Ulthera(TM) Receives First-Ever FDA Clearance to Market Ultrasound
MESA, Ariz., Sept. 16 /PRNewswire/ — Ulthera, Inc., a therapeutic ultrasound medical device company serving the $30 billion global aesthetics market, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the use of its Ulthera(TM) System to achieve a non-invasive eyebrow lift. The Ulthera System is considered a first-of-its-kind technology, […]
Merz Pharmaceuticals’ Belotero(R) Balance PMA Filing Formally Accepted for Review by the FDA
GREENSBORO, N.C. — Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz’s premarket approval (PMA) application for Belotero(R) Balance. Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology. This application seeks […]
