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Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data fro...[ Price : $8.95]
FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.[ Price : $8.95]
Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...[ Price : $8.95]
Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...[ Price : $8.95]
FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides u...[ Price : $8.95]
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.[ Price : $8.95]
FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model a...[ Price : $8.95]
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at stre...