Endo and Allergan agree to pay $15 million to settle a suit by two Ohio counties accusing several drug companies and drug distributors of being respon...
Sen. Gary Peters asks FDA acting commissioner Ned Sharpless to answer questions on the agencys current and future efforts to address drug shortages.
FDA warns Polymer Technology Systems about multiple violations in its manufacturing of in vitro diagnostic medical devices.
FDA warns TG United about CGMP and other violations in its production of finished drugs.
Federal Register notice: FDA announces a 10/16 Advisory Committee meeting to review a Shionogi NDA for antibiotic for urinary tract infections.
FDA highlights a new Warning Letter to a Chinese drug manufacturer as evidence of its increased oversight of over-the-counter drug manufacturing.
Federal Register notice: FDA sets a 10/30 advisory committee meeting to review an Agile Therapeutics transdermal contraceptive.
Federal Register notice: FDA announces a pilot program to test the processing and analysis of nonclinical study data provided electronically for the C...