A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators.
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.
A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators.
NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.
Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.
FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a closely watched Phase 3 study.
