Drug/diagnostic combinations as a legal defense?
This article was originally published in The Gray Sheet
Executive SummaryNeglecting to use companion diagnostics to improve drug therapy management may open a new market for malpractice lawyers, according to Stephen Little, CEO of Manchester, UK-based genotyping firm DxS Ltd. In London, addressing a recent conference on global diagnostic trends, Little claims "it wouldn't be unreasonable to assume that if an individual is given a drug" without prescribing an available diagnostic to guide patient response, a lawsuit against the physician could follow in the case of adverse events. Conversely, diagnostics that can gauge predispositions to adverse events prior to treatment will help physicians avert malpractice threats, he says...
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.