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Federal Register notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in cond...
Federal Register notice: FDA makes available a draft guidance entitled REMS Assessment: Planning and Reporting.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...
Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) introduce legislation aimed at keeping drug prices down by increasing competition in the ge...
Federal Register notice: FDA makes available a final guidance entitled Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility...
Federal Register notice: FDA issues a guidance, Safety and Performance Based Pathway, that discusses the agencys current thinking on expanding the con...