FDA

Responding to the coronavirus outbreak, a federal agency relaxes requirements on medical device manufacturers.

In the face of a massive viral outbreak, a federal regulator issues unprecedented guidance on validating COVID-19 testing.

FDA clarifies enforcement priorities for medical device clinical decision support software.

Regulators and regulatory scholars alike need to keep in mind regulation’s essential human element.

Online announcement declares that new tobacco age restrictions are effective immediately.

FDA’s approval of an Ebola vaccine can serve as a framework for drug development during other epidemics.

As mobile medical applications continue to proliferate, regulators lack a solid framework for oversight.

A federal task force proposes regulatory solutions to mitigate drug shortages.

As people consume less meat and more meat alternatives, regulators have a role to play in ensuring accurate consumer information and safety.

A changing research environment means regulators and institutional review boards must adapt.

Lawyers and regulators are concerned about the lack of regulations for the use of robotic technology in surgeries.

FDA warns consumers that the agency has not evaluated most CBD products and cannot say they are safe.