Federal Register notice: FDA seeks comments on a new information collection entitled Empirical Study of Promotional Implications of Proprietary Prescr...
FDA Review has posted the Federal Register notices for the week ending 1/17/2020.
FDA Review posts product approval summaries for the week ending 1/18/2020.
FDA approves a new indication for Novo Nordisks Ozempic (semaglutide) injection 0.5 mg or 1 mg reducing the risk of major adverse cardiovascular even...
FDA seeks comments on new proposed research by CDERs Office of Prescription Drug Promotion on promotional implications of proprietary drug names.
FDAs Anesthetic and Analgesic Drug Products Advisory Committee issues a split vote (6 to 6) on the approval of Durect Corp.s surgical pain drug Posimi...
Federal Register notice: FDA requests nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committee.
A new FDA safety communication recommends that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer ...