Federal Register notice: FDA makes available a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Chang...
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FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinical trials.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...
