A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee temporary voting memb...
A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.
CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency.
FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval fo...
An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1...
FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1.
A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.
The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million...
