FDA chief counsel Stacy Cline Amin tells FDLI that the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will...
FDA issues a draft guidance recommending the inclusion of premenopausal women in breast cancer drug clinical trials.
FDA warns Battelle that the medical device reporting procedure and processes it has in place under an EUA for its respirator decontamination system ar...
The University of Kentucky asks FDA to recall two lots of acetazolamide after its tests show reduced levels of the active ingredient and increased imp...
FDA denies a Public Citizen petition on Amags Makena while starting the process to have the drug withdrawn because its confirmatory trial did not demo...
Federal Register notice: FDA announces an 11/2 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Adv...
House Energy and Commerce Committee Democratic leaders blast HHS secretary Alex Azar for a grave error in pulling the review of laboratory-developed t...
Eton Pharmaceuticals files an NDA for topiramate oral solution as a monotherapy for treating certain seizures and preventing migraines.