George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

Aldeyra submitted the single successful trial to the FDA over the summer and the agency accepted the resubmitted NDA for ...

"This risk is exacerbated by the fact that there is currently no proven, widely accepted standard to determine marijuana ...

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...

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

An FDA panel of experts has called for a loosening of regulations and expanding access to testosterone replacement therapy.

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 ...

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.

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