The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire ...

Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS ...

The FDA has begun traceback efforts, suggesting that investigators have identified some possible pathogen sources. However, the FDA has not reported what food it is tracing and has not begun on ...

It also helps other companies define the "requirements related to labeling and performance testing," per the FDA, so similar at-home tests will have an easier time making it to the market and ...

State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry's racial bias, which has caused delays in treatment and worse health outcomes, and more ...

If you care about food safety, then Jim Jones matters to you. A year into his tenure as Deputy Commissioner for the Human Foods Program, ...

Last week, the outgoing leader of the FDA’s devices center ... This week, the agency made it official. The Center for Devices and Radiological Health (CDRH) confirmed the appointment Tuesday.

After Andrew Soukup of Covington & Burling and Jay Lefkowitz of Kirkland & Ellis argued the motion to dismiss for the ...

One FDA official said they believe the original studies using the drug were “methodologically unsound and do not match today’s standard.” The drug is supposed to relieve congestion by ...

As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...

The proprietary formula in the Riize Hair products combines the most effective FDA approved prescription hair growth ingredients available - minoxidil, finasteride and biotin. The Riize Hair product ...