FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does not reduce sponsor accountability, according to a new client alert from Crowell & Moring.
FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does not reduce sponsor accountability, according to a new client alert from Crowell & Moring.
FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agency is “following the science” while accelerating broader reforms aimed at speeding approvals.
FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facility that produces sterile drug products.
