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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 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...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Chinas Bio-Thera Solutions.[ Price : $8.95]
FDA awards Partner Therapeutics a Commissioners National Priority Voucher for a new Bizengri indication.