[ Price : $8.95]
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients wi...[ Price : $8.95]
A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medic...[ Price : $8.95]
FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal z...[ Price : $8.95]
FDA publishes a guidance on implementing the eCopy submission program for medical devices.[ Price : $8.95]
FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices cove...[ Price : $8.95]
FDA reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather th...[ Price : $8.95]
The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.[ Price : $8.95]
CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism ...