A new FDA study of 252 difficult-to-make prescription drugs finds that U.S.-marketed products consistently meet quality standards even when manufactur...
FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic data submission portal...
FDA issues a priority review voucher to Genentech for gaining approval of a rare pediatric disease product application Evrysdi (risdiplam).
Federal Register notice: FDA issues a final rule to remove the specified test for detecting the presence of Mycoplasma for live virus vaccines and ina...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dompe Farmaceuticis Oxervate (cenegermin-bkbj)....
Federal Register notice: FDA announces an 8/28 virtual public meeting entitled Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments...
FDA cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles to help women with st...