A state court jury in New Jersey hands down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective p...
Federal Register notice: FDA submits to OMB for approval an information collection extension for Notification of the Intent To Use An Accredited Perso...
FDA alerts health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in s...
Federal Register notice: FDA makes available a guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Popul...
Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants.
Federal Register notice: FDA announces a 5/4 Reagan-Udall Foundation annual public meeting to discuss its activities and how it supports the agency.
Premier Pharmacy Labs recalls several lots of morphine sulfate, hydromorphone HCl and neostigmine methylsulfate due to a potential lack of sterility a...
FDA approves a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants.