In Brief: FDA Dental Products Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA Dental Products Panel: Slated to meet Feb. 27-29 at the Bethesda Marriott Hotel, Maryland. On Feb. 27, the panel will review a premarket approval application for "a bone filling device for periodontal use." On Feb. 28, the panel will vote on a PMA for a "dental laser for hard tissue use" and "discuss the reliability and accuracy of digital subtraction radiography and its use in the clinical design of trials evaluating treatment and/or progression of periodontis." On Feb. 29, the panel, "with representation from the Dental Drug Products Plaque Subcommittee," will discuss "public health issues relevant to a new drug application for a dentifrice "for use in the prevention of caries, plaque, and gingivitis." For more information contact Carolyn Tylenda at 301/443-8879...
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.