Federal Register notice: FDA determines for patent extension purposes the regulatory review period for CVRxs Barostim Neo, indicated for improving sym...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that discuss the design of bioequivalence s...
Federal Register notice: FDA requests that any consumer organizations interested in participating in the selection of voting and nonvoting consumer re...
FDA clears a Rapid Medical 510(k) for its TigerTriever revascularization device for use in treating ischemic stroke.
EMD Serono suggests three topics for FDA consideration for an upcoming workshop on best practices for developing and applying disease progression mode...
FDA cautions Michael Levin for violations in his work as a clinical investigator for a clinical study.
FDA clears an Aurora Spine 510(k) for its proprietary Apollo Anterior Cervical Plate system, featuring a 1.9mm design with hyper-angulation variabilit...
Exela petitions FDA to reassign a therapeutic equivalence code to its nicardipine NDA product and refund PDUFA user fees that it believes should not h...