In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On January 3, 2025, the Department of Defense, General Services Administration, and National Aeronautics and Space Administration (collectively, the Federal Acquisition Regulation (FAR) Council) issued a final rule, Improving...more
Earlier this week, efforts to reduce U.S. reliance on biotechnology companies in China stalled when the BIOSECURE Act (“BIOSECURE” or the “Act”) was left out of this week’s continuing resolution (CR). As a result, BIOSECURE...more
In 2024, the federal government continued to shape the research compliance landscape with significant developments for research institutions across several areas. Key updates included the continued implementation of research...more
In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more
The White House Office of Science and Technology Policy (OSTP) has issued long-awaited Guidelines for Research Security Programs at Covered Institutions (“Guidelines”), which outline how federal research agencies must require...more
The U.S. Office of Management and Budget (OMB) has released its long-awaited “Guidance for Federal Financial Assistance” to revise the regulations previously known as the OMB Uniform Guidance. With Federal grant funding...more