FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations of the products imm...
Former FDA attorney William McConagha moves from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation and enforcement pract...
Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Tre...
Federal Register notice: FDA announces a 4/23 Medical Imaging Drugs Advisory Committee meeting to review an Avid Radiopharmaceuticals NDA for a radioa...
FDA denies a petition asking it to require compliance with a guidance and taken enforcement action against non-compliant manufacturers of methscopolam...
FDA issues Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizumab) to include a 400...
ResMed recalls its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure.
FDA issues an Establishment Inspection Report to Aurobindo Pharma for its Pashamylaram Unit 4 injectable manufacturing facility.