Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Dhruva, Kesselheim, and Redberg are all professors of medicine.
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...
Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...
Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
The Senate on Wednesday approved the 21st Century Cures Act, which aims to boost funding for medical research, enhance mental healthcare research, provide more money to fight the national opioid ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
FDA announcement of the creation of a Digital Health Advisory Committee causes a 7.2% decline in the iShares U.S. Medical Devices ETF. Digital health industry shows immense potential, driven by ...
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