Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspections of CDER-regul...
Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of the agency.
CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug Law Institutes annua...
Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion since last fall.
Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agencys National Priority Voucher review program following an internal disagreem...
A Brookings Institution health economist voices support for FDAs revisions to a guidance on questions and answers about biosimilar development and the...
Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data from China, Russia, Nor...
FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.
