FDA commissioner Robert Califf asks Congress to give the agency the authority to set standards for postmarket evaluation of artificial intelligence in...
FDA warns Auckland, New Zealand-based Adept Medical about Quality System and other violations in its production of ventilation tubes.
FDA warns Milan, Italy-based Eurosirel about CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinical trials.
The DC federal court agrees with FDA that a suit against the agency over identifying an attorney in a regulated company on a form FDA-483 should be di...
FDA accepts for review a Satsuma Pharmaceuticals NDA resubmission for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with...
Based on just-reported Phase 3 trial data, Axsome Therapeutics says it will submit an NDA for on AXS-12 (reboxetine) and its use in treating narcoleps...
FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Huma...
