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Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufac...[ Price : $8.95]
AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.[ Price : $8.95]
Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect te...[ Price : $8.95]
FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).[ Price : $8.95]
A Massachusetts federal judge sentences the former New England Compounding Center operations director to five months in jail for c...[ Price : $8.95]
FDA clears a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lateral lumbar...[ Price : $8.95]
FDAs Cardiovascular and Renal Drugs Advisory Committee votes 8 to 3 against recommending approval of Cytokinetics omecamtiv mecarb...[ Price : $8.95]
FDA accepts for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises...