Attorney Kate Stewart says the FBI is warning about the cybersecurity risk in FTP servers in healthcare facilities operated in an anonymous configurat...
Federal Register notice: FDA extends the comment period for the draft guidance for industry #187 Regulation of Intentionally Altered Genomic DNA in An...
Federal Register notice: FDA identifies 71 Class 1 devices that are now exempt from premarket notification requirements.
FDA determines that Amgens erythropoiesis-stimulating agents epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) no longer require a Risk...
FDA warns Abbott about QS violations at its Sylmar, CA, manufacturing facility.
The former CEO of Action Packing and Design, Paul Rodriguez, pleads guilty to trafficking in counterfeit labels and packaging.
FDA clears a Ventec Life Systems 510(k) for VOCSN, a portable life support device that combines five respiratory therapies ventilation, oxygen, cough...
FDA clears a United Orthopedic 510(k) for its E-XPE polyethylene knee insert that is designed to provide patients with knee replacements with reduced ...