FDA accepts a letter of intent for a wearable sensor-based digital outcome measure designed to assess foot drop severity and gait impairment in patien...
A new study finds that a machine learning-based approach to FDA's 510(k) medical device clearance process could reduce device recalls by nearly one-th...
FDA warns Chatsworth, CA-based kdc/one Chatsworth about CGMP violations in its production of finished drugs.
A citizen petition seeks a safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mec...
FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulato...
FDA recommends that Compass Therapeutics conduct an additional clinical trial demonstrating an overall survival benefit before submitting a BLA for to...
FDA warns Houston, TX-based Empower Pharmacy that it is illegally compounding GLP-1 drugs under conditions that violate CGMP regulations.
Ardelyx says it incorporated lessons from FDA's recent prescription drug advertising enforcement actions into its first television advertising campaig...
