SUMMIT TECHNOLOGIES' EXCIMER LASER PROMOTIONAL VIOLATIONS
This article was originally published in The Gray Sheet
Executive Summary
SUMMIT TECHNOLOGIES' EXCIMER LASER PROMOTIONAL VIOLATIONS alleged by FDA in an Oct. 27 warning letter to the company. The warning letter cites three violative situations regarding promotion of the excimer laser, one involving the sale of the device. The laser has not yet been approved by FDA, but the agency's Ophthalmic Devices Panel has recommended approval for both photorefractive keratectomy ("The Gray Sheet" Oct. 24, p. 3) and phototherapeutic keratectomy ("The Gray Sheet" March 28, p. 13).
You may also be interested in...
Behavioral Health Company Two Chairs Secures $72M In Equity And Debt Infusion
Two Chairs, which uses algorithms to match the right therapists with patients, secured $72m in investment to expand its business.
Teva Says The Time Is Right For Two Big Immunology Biosimilar Launches
US market access senior VP Tom Rainey talks to Scrip about the upcoming launches of biosimilar versions of Humira and Stelara.
Fenty Cleanser Performance Claims Supported, But Influencer Videos Need Disclaimers – NAD
A National Advertising Division review of claims by LVMH-owned Fenty Skin determined makeup- and dirt-removal representations were substantiated by a study and subject questionnaire, but demo videos from paid endorsers must include disclosures about material connections in accordance with FTC guidelines.