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...
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.
FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection...
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scient...
