Federal Register notice: FDA determines that Mercks Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effectiveness concerns.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FDA releases a draft guidance with recommendations on how to include information on gluten content in certain drug products.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FDA issues a draft guidance explaining some circumstances under which the agency may refuse to file a new or supplemental NDA or BLA.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