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FDA approves a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for up to one week of ...[ Price : $8.95]
FDA approves a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA i...[ Price : $8.95]
FDA has generally spent PDUFA user fee collections appropriately, according to an HHS Inspection General report.[ Price : $8.95]
FDA clears a Nexxt Spine 510(k) for the Nexxt Matrixx System, 3-D printed porous titanium equipment for creating interbody and ver...[ Price : $8.95]
Harvard Medical School researchers suggest ways to improve noninferiority clinical trials.[ Price : $8.95]
FDA issues a guidance explaining GDUFA requirements for holders of Type II API DMFs referenced in ANDAs, PSAs, or amendments to ei...[ Price : $8.95]
The Federal Trade Commission sets an 11/8 workshop on drug market competition with an address by FDA commissioner Scott Gottlieb.[ Price : $8.95]
FDA issues a guidance on submitting to prior approval supplements and their amendments to FDA.