Association for Molecular Pathology wants a Senate panel to consider a legislative alternative to FDA’s proposed lab developed test (LDT) framework and let CMS or a third party assess high-risk LDT procedures for clinical validity.
The Association for Molecular Pathology has asked a Senate committee to consider its alternative to FDA’s proposed laboratory developed test (LDT) framework, giving the Centers for Medicare and Medicaid Services regulatory jurisdiction over the tests under a beefed-up Clinical Laboratory Improvements Amendments law.
The pathologists group, one of several that expressed disappointment with FDA’s LDT framework early on Also see "Lab Groups’...
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
