Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical Devices Posted in Government. The Justice Department announced that a federal... Continue reading
FDA and CMS Statement: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made Posted in Government. The following is attributed to Jeff Shuren, M.D.,... Continue reading
FDA Authorizes Florida’s Drug Importation Program Posted in Government. The U.S. Food and Drug Administration authorized Florida’s... Continue reading
Former Employee of Medical Device Manufacturer Pleads Guilty to Forging Two FDA Clearance Letters for Medical Devices Posted in Government. A Philadelphia-area man pleaded guilty for his role... Continue reading
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Healthcare Providers Posted in Cybersecurity. The U.S. Food and Drug Administration (FDA) is informing... Continue reading
AirStrip ONE web client receives U.S. regulatory clearance Posted in Government, Press Release. The U.S. Food and Drug Administration has issued... Continue reading
Mobile health’s regulatory path Posted in Uncategorized. Dr. Anand K. Iyer, Chief Strategy Officer, WellDoc For... Continue reading