MDR USER FACILITY ADVISORY PANEL BEING CONSIDERED BY FDA; AGENCY PLANS TO INSPECT SOME USER FACILITIES BUT HOPES MORE CAN BE REVIEWED BY OUTSIDE GROUPS
This article was originally published in The Gray Sheet
FDA is considering establishing an advisory panel to assist in its implementation of medical device reporting requirements for user facilities, Larry Kessler, director of the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, said during a May 7 FDA teleconference focusing on the recently finalized MDR rules.
You may also be interested in...
Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.
Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.
Biopharma is working on a reputation renaissance as the public looks to industry for treatments and vaccines for the COVID-19 epidemic and drug pricing concerns take a back seat.