Winston & Strawn attorneys outline an FDA draft guidance on the enhanced Drug Supply Chain Security Act system for tracking and tracing drugs at the p...
Emergent Biosolutions responds to an FDA-483 about issues at its Bayview facility that manufactured Covid-19 vaccines and was the subject of a cross-c...
FDA grants iStar Medical an IDE to begin a pivotal trial with its Miniject implant in over 350 patients with primary open angle glaucoma.
FDA clears a Palliare 510(k) for the END-200 tubeset that expands the use of its EVA15 continuous pressure insufflation technology from laparoscopic s...
BIO discusses how three FDA emergency Covid-19 guidances may inform future inspection practices after the public health emergency ends.
FDA approves VetDCs Tanovea (rabacfosadine injection) to treat lymphoma in dogs.
FDA says it is working with NuVasive to resolve safety issues with its MAGEC growing spinal rod system.
CNN reports that Janet Woodcock is no longer the front-runner to be named FDA commissioner due to concerns voiced by some Senate Democrats.