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

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

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

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 ...

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 black-box warning is not a neutral informational update. It is the FDA’s most aggressive regulatory communication via product labeling, intended to alert clinicians and patients to risks so grave ...

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

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

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

Dr. Helen Bernie said on a Dec. 10 panel hosted by the U.S. Food and Drug Administration that serum testosterone "is one of ...