An edict issued without warning in February 2025 by the National Institutes of Health (NIH), having the effect of slashing funding by the NIH across the board, has been put on a nationwide hold for now by a federal court in...more
The U.S. Department of Health and Human Services (HHS) on Feb. 28, 2025, issued a policy statement limiting the circumstances under which HHS agencies must publish proposed rules for public comment before the rules are...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more