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Federal Register notice: FDA determines that Mercks Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effe...[ Price : $8.95]
FDA asks the Office of Management and Budget to review its proposal for two studies determining how well consumers and healthcare ...[ Price : $8.95]
FDA warns Koreas Seindni Company about CGMP and labeling violations in its manufacturing of finished drug products.[ Price : $8.95]
FDA releases a draft guidance with recommendations on how to include information on gluten content in certain drug products.[ Price : $8.95]
CDRH staffers say the number of IDEs submitted for early feasibility studies has more than doubled in the second year of the progr...[ Price : $8.95]
FDA issues a draft guidance explaining some circumstances under which the agency may refuse to file a new or supplemental NDA or B...[ Price : $8.95]
FDA expands the approved use of GlaxoSmithKlines Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis wit...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for Orphan Products Development; FDA Orphan Dru...