CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to protect public health du...
A Presidents Council of Advisors on Science and Technology report on patient safety includes two recommendations for FDA action.
A white paper by the Duke Margolis Center for Health Policy calls for a new government coordinating effort, the Prevent Drug Shortages Initiative, to ...
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...
