George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...

A regulation with potentially major implications for the pharmaceutical industry has cleared its review, teeing it up for ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

"This risk is exacerbated by the fact that there is currently no proven, widely accepted standard to determine marijuana impairment at the roadside or before a driver begins operating a vehicle, ...

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

The FDA is being transformed from an independent regulator into a high-stakes bargaining chip for White House deal-making.

Wednesday's House hearing on restoring trust in the FDA included something that doesn't happen often: testimony from an industry representative begging for his industry to be regulated. "Lack of ...

The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER), continuing the rapid ascent of a physician who rose to prominence during the ...

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