Pedicle Screw FDA Status Irrelevant To Informed Consent, N.J. Court Finds
This article was originally published in The Gray Sheet
Executive Summary
Notifying patients of the FDA regulatory status of devices used in surgical procedures is non-essential to the informed consent process, according to a New Jersey appellate court
You may also be interested in...
Supreme Court Leaves FDA To Its Own Devices In Regulating Fraud Claims
The Supreme Court's Feb. 21 decision in Buckman Co. v. Plaintiffs Legal Committee defends off-label use as a vital "corollary" to FDA's regulatory scheme, while also investing sole authority in the agency to determine whether premarket submissions are fraudulent.
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.