University researchers say that FDA was late in ordering mesh implants used in pelvic organ prolapse from the market, possibly due to positive patient...
CDRH and CDER launch a new Web resource to provide the current science on gene-drug associations.
FDA approves a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain.
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FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations of the products imm...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...