FDA principal deputy commissioner Amy Abernethy tells a Webinar that the agencys large-scale and ambitious plan to modernize its information technolog...
FDA says a Teleflex Medical recall of Comfort Flo humidification systems is Class 1.
FDA grants priority review to a BioMarin investigational gene therapy for hemophilia A.
Sen. Grassley predicts that his bipartisan drug pricing legislation will pass by 5/20.
FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations of the products imm...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...