Novavax expects to apply this month for an FDA EUA for its Covid-19 two-dose vaccine.
FDA warns Carson City, NV-based Alpha Aesthetics about Quality System and Medical Device Reporting violations in its manufacturing of silicone facial ...
FDA issues a guidance with recommendations for remotely using digital health technologies in clinical investigations.
University of Minnesota researchers ask FDA to approve an EUA for the generic antidepressant fluvoxamine as a Covid-19 treatment.
FDA places a clinical hold on 10 Gilead trials of an investigational HIV drug.
FDA Webview posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).
FDA warns Chinas Global Medical Production about Quality System and Medical Device Reporting violations in its production of medical devices.
FDA warns Chinas Guangzhou Shiruoni Cosmetics Co. about adulterated and misbranded Impacta hand sanitizer that was marketed in the U.S.