FDA issues a draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.
FDA warns Medtronic about Quality System and Medical Device Reporting violations at its Northridge, CA, manufacturing facility.
FDA issues a draft guidance on assessing the credibility of computational modeling and simulation in medical device submissions.
FDA issues an emergency use authorization for Mercks molnupiravir to treat mild-to-moderate Covid-19 in some adults.
Padagis recalls three lots of 12 g spray bottles of nitroglycerin lingual spray labeled for Perrigo due to the potential for a defective dispenser.
FDA grants an emergency use authorization for Pfizers Paxlovid, the first oral treatment for some Covid-19 cases.
FDA tentatively approves Amphastars vasopressin injection, a generic form of Pars Vasostrict.
FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.