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CDER director Janet Woodcock says Howard Sklamberg will become director of the Centers Office of Compliance early next year.[ Price : $8.95]
Endo asks FDA to act quickly in determining that its non-crush resistant Opana ER was withdrawn from the market for reasons of saf...[ Price : $8.95]
Forest Laboratories submits an NDA for cariprazine, indicated for treating schizophrenia and manic or mixed episodes associated wi...[ Price : $8.95]
FDA rejects a Public Citizen petition seeking a boxed warning and other changes to labeling for Sucampo and Takedas constipation d...[ Price : $8.95]
FDAs Minneapolis District Office warns InCentral Medical about Quality System violations in its manufacturing of the InTone female...[ Price : $8.95]
FDA approves an Avaxia Biologics IND for AVX-470 for treating of ulcerative colitis.[ Price : $8.95]
The Federal Trade Commission supports Mylans lawsuit contending that Warner Chilcott used product reformulations to delay market e...[ Price : $8.95]
FDA clears an AtCor Medical 510(k) for its SphygmoCor XCEL device, a new blood pressure cuff-based system that allows brachial and...