Generic drugs lobbying arm Association for Accessible Medicines says new legislation introduced last week may have the unintended impact of reducing c...
FDA Review has posted the Federal Register notices for the week ending 2/1/2019.
FDA Review posts product approval summaries for the week ending 2/1/2019.
CDER Therapeutic Biologics and Biosimilars Staff director Leah Christl announces her departure to pursue other opportunities.
Federal Register notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in cond...
Federal Register notice: FDA makes available a draft guidance entitled REMS Assessment: Planning and Reporting.
Terrific Care/Medex Supply recalls all lots of Roche Diagnostics CoaguChek XS PT Test Strips that were manufactured 10/2017 to 5/2018 due to inaccurat...
West Pharmaceutical Services recalls its Vial2Bag fluid transfer system that was manufactured between 3/15/2016 and 1/8/2019 due to the possibility th...