This article was originally published in The Tan Sheet
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...
Caught in a ‘vaccine nationalism’ crossfire a year ago, CureVac is now well placed to become a commercial entity – just as long as its mRNA platform can deliver.
Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.
Prescience Point Capital is trying to reshuffle the board of directors leading regenerative medicine company MiMedx, arguing the company’s current board has destroyed shareholder value. The company's tock is selling for about a third of its potential value, according to Prescience.