Guidances for third-party eligible devices
This article was originally published in The Gray Sheet
Executive Summary
FDA releases guidance documents on its website (www.fda.gov/cdrh) for seven in vitro diagnostic devices and a surgical lamp. The eight products were included in a list of 26 additional devices for which the agency plans to develop guidance prior to the Nov. 21 start-up of its "Accredited Persons" third-party review program ("The Gray Sheet" July 13, p. 6)
You may also be interested in...
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.