An FDA advisory committee votes 16 to 0 that current scientific data do not support the effectiveness of the over-the-counter phenylephrine (10mg) as ...
Mallinckrodt recalls its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces the flow of ventila...
A Florida federal jury finds two defendants guilty of conspiring to falsify clinical trial data for profit.
Federal Register notice: FDA announces the over-the-counter (OTC) monograph order request fee rates under the OTC monograph drug user fee program for ...
Federal Register notice: FDA issues an order to permanently debar Mayya Tatsene from providing services in any capacity to a person that has an approv...
FDA approves a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia who have no other suitable endovascular...
FDA issues its first Postmarket Device Safety-Related Communications report to Congress that details 45 safety-related communications issued in 2022.
The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of Appeals that would ...
