FDA warns Boca Raton, FL-based Cosmetic Solutions about CGMP and unapproved new drug violations in its manufacturing of finished drugs.
The Office of Pharmaceutical Quality FY 2023 annual report says drug quality assurance inspections were up 40% over FY 2022 and mutual recognition agr...
FDA lists three planned 2024 enhancements to the CDRH electronic medical device reporting system.
Medline Industries recalls its Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube.
Biogen and Public Citizen call on FDA to address issues in its draft guidance on developing drugs to treat early Alzheimers disease.
Israeli researchers say more effort must be made to increase the number of women enrolled in medical device clinical trials.
FDA grants Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis in combination with ursodeoxycho...
Federal Register notice: FDA announces the renewal of its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years.
