FDA clarifies its generic drug approval process in an effort to encourage market competition.
The most surprising regulatory dimension of the coronavirus crisis may center on the lifting of rules.
Critics of a proposed rule to import drugs from Canada cite safety concerns and other potential problems.
The federal government seeks authority over stem cell treatments but risks thwarting medical advancement.
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.