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.
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.
FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic im...
