FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose mon...
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications as Used by the Food...
FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.
FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.
FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Ivenix Infusion System.
FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.
Four stakeholders respond to an FDA request for comment on guidance best practices.
Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match congressional intent in ...
