Federal Register notice: FDA sends to OMB a proposed information collection entitled Medical Conference Attendees Observations About Prescription Drug...
Arnold & Porter attorneys give practical tips for attempting to include real-world evidence in advertising for medicinal products.
Winston & Strawn attorneys outline an FDA draft guidance on the enhanced Drug Supply Chain Security Act system for tracking and tracing drugs at the p...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.