FDA issues two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer products.
FDA issues a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for healthcare providers to ...
FDA issues a guidance entitled Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic that outlines circ...
After gaining some media attention, a new FDA safety update says it is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, ...
FDA sends Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empagliflozin 2.5 mg and...
Federal Register notice: FDA makes available a final guidance entitled Required Warnings for Cigarette Packages and Advertisements: Small Entity Compl...
Federal Register notice: FDA issues a final rule to establish new health warnings for cigarette packages and advertisements.
Federal Register notice: FDA reopens the comment period for a 6/1/2018 notice on a shared system risk evaluation and mitigation strategy draft guidanc...