OTC devices
This article was originally published in The Tan Sheet
Executive Summary
Ear, Nose & Throat Devices Panel will meet jointly with the Dental Products Panel of the Medical Devices Advisory Committee on Oct. 6 to "discuss general issues surrounding the prescription use versus over-the-counter use of devices intended to treat snoring or mild to severe obstructive sleep apnea (OSA)," FDA announces in an Aug. 18 Federal Register notice. Panelists will pay special attention to "the ability of the patient to self diagnose and treat OSA [and] the types of clinical data that would be needed to support an OTC intended use." Between 8 am and 8:30, the meeting will be closed to the public; from 8:30 am to 5:30 pm, the public can sit in at the Hilton Washington DC North/Gaithersburg...
You may also be interested in...
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.