The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workload.
The Biosimilars Forum and PhRMA say they support the third biosimilar user fee agreement negotiated with FDA.
CBER Office of Tissues and Advanced Therapies director Wilson Bryan addresses the lessons learned from FDAs limited experience in approving seven gene...
FDA issues an emergency use authorization for AstraZenecas Evusheld monoclonal antibody Covid pre-exposure prevention for some adults and pediatric pa...
Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal testing determining the ...
Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates.
Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug product regulation by con...
Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the generic device type: ...