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The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workl...[ Price : $8.95]
The Biosimilars Forum and PhRMA say they support the third biosimilar user fee agreement negotiated with FDA.[ Price : $8.95]
CBER Office of Tissues and Advanced Therapies director Wilson Bryan addresses the lessons learned from FDAs limited experience in ...[ Price : $8.95]
FDA issues an emergency use authorization for AstraZenecas Evusheld monoclonal antibody Covid pre-exposure prevention for some adu...[ Price : $8.95]
Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal test...[ Price : $8.95]
Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of ...[ Price : $8.95]
Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug produ...[ Price : $8.95]
Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the g...