FDA warns Luminex Corp. about QS and MDR violations in its production of multiplexing systems.
Federal Register notice: FDA makes available a guidance on Unique Device Identification Compliance Dates for certain dates.
FDA approves Genentechs outpatient breast cancer drug Phesgo.
Federal Register notice: FDA makes available a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population.
FDA approves a new indication for Mercks Keytruda to treat specified forms of colorectal cancer.
FDA publishes a draft guidance with general recommendations for sponsors developing anti-infective drug products for pediatric patients.
FDA issues an immediately effective guidance for developers of Covid-19 vaccines saying any vaccine should be effective in at least 50% of those vacci...
FDA reiterates warning against hand sanitizers containing methanol.