Federal Register proposed rule: FDA proposes to amend its medical product intended use regulations to describe the types of evidence relevant to deter...
FDA denies without comment on potential future action a Taiho petition seeking restrictions on generic versions of its Lonsurf tablets.
FDA says it is ordering labeling changes to benzodiazepines to highlight risks of abuse, misuse, addiction, withdrawal symptoms, etc.
FDA grants priority review for Pfizers Xalkori sNDA to treat some pediatric lymphoma patients.
FDA commissioner Stephen Hahn testifies on Capitol Hill to reassure lawmakers and the public that a transparent science- and data-based review, and no...
Federal Register notice: FDA determines that Carmel Biosciences Prexxartan (valsartan) oral solution was not withdrawn due to safety or effectiveness ...
FDA commissioner Stephen Hahn and CDC director Robert Redfield dismiss notions that a deep state operates within their agencies intent on damaging pre...
FDA warns HNC products about significant violations of CGMP regulations in its production of OTC drugs.