Following several recent initiatives, the FDA's newest rare disease framework sets out to standardize the agency's approach ...

The tailored framework arrives amid renewed focus on rare diseases across US health agencies.

At a recent confirmation hearing, senators sought assurances from Heidi Overton that advisory committees won’t become another ...

A revamped regulatory framework may give investors less of a “guessing game” as they weigh chances for drug approvals, one analyst said.

The FDA's discussion paper around a proposed approach to GenAI-based medech regulation is open to stakeholder feedback until ...

FDA's proposed new rule for food additive has some reasonable provisions but also one that could expand use of toxic ...

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...

A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

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 ...