FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his retirement paperwork ea...
A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evidence-based vaccine ...
The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency the authority to ord...
FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.
FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.
FDA warns Conway, AR-based Turbare Manufacturing about CGMP and other violations in its work as an outsourcing facility producing sterile drug product...
FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling...
A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby, the first ...
