FDA warns Kingston Pharma about CGMP and other violations in its manufacturing of finished pharmaceuticals.
FDA approves a W. L. Gore PMA for the GORE CardioForm ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects.
FDA secures summary judgment against U.S. Stem Cell Clinic for adulterating and misbranding a stem cell product not approved by FDA and failing to com...
FDA and Harvard Medical School staff discuss the history and use of the agencys Sentinel medical product safety system.
FDA warns ActiveHerb Technology about multiple violations in its manufacture and sale of unapproved and misbranded new drugs.
FDA clears a Misonix 510(k) for Nexus, an ultrasonic surgical platform.
The House Appropriations Committee marks up and passes the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an ...
Boehringer Ingelheim expresses general support for an FDA final guidance on considerations in demonstrating interchangeability with a reference produc...