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...
Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it ...
FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceutical ingredient manu...
