K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On July 24, 2025, the Trump Administration turned to the U.S. Supreme Court to block U.S. District Judge Young’s preliminary injunction prohibiting the National Institutes of Health (NIH) from cutting hundreds of grant...more
Stirrings in Congress in the early 1980s, initially led by a young Al Gore, Jr., focused on emerging concerns of misconduct in scientific research. Following public interest and the resulting congressional hearings, federal...more
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...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