FDA releases its latest batch of Warning Letters that include Sage Moon Apothecary and Yuyao Yijia Daily Chemical Co.
CDERs Office of Prescription Drug Promotion says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs, launc...
Federal Register notice: FDA withdraws a 1/21-posted final rule that provided additional information on the content and format of reports intended to ...
Federal Register notice: FDA withdraws a 1/21-posted final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requ...
The Advanced Medical Technology Association tells FDA that early stakeholder engagement is critically important when the agency is considering medical...
Merck discontinues developing two Covid-19 vaccine candidates, V590 and V591 based on Phase 1 data showing that the immune responses were inferior to ...
FDA clears a Theranica 510(k) for its Nerivio therapeutic device for an expanded indication for acute treatment of episodic or chronic migraine in pat...
FDA accepts for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholesta...