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FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter co...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications...[ Price : $8.95]
FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Iven...[ Price : $8.95]
FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.[ Price : $8.95]
Four stakeholders respond to an FDA request for comment on guidance best practices.[ Price : $8.95]
Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match cong...