FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently.
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scientific workforce, modernizing inspections and reversing what he described as a loss of U.S. leadership in early-stage drug development.
FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently.
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scientific workforce, modernizing inspections and reversing what he described as a loss of U.S. leadership in early-stage drug development.
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.
