FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CGMP violations.
FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.
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.
