Boston Scientific IDE Violations Related To SCORES Trial Cited By FDA
This article was originally published in The Gray Sheet
Boston Scientific's failure to ensure investigator compliance at certain centers involved in the SCORES clinical trial for the Radius self-expanding coronary stent is highlighted in a July 23 FDA warning letter to the firm's Scimed Life Sciences division citing the firm for investigational device exemption violations.
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.