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 February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more
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
On 17 December 2019, the U.S. Department of Education (ED) published in the Federal Register notice of a new information collection request (ICR) related to reporting requirements under Section 117 of the Higher Education Act...more
12/31/2019
/ Department of Education ,
Disclosure Requirements ,
Education Reform ,
Educational Institutions ,
Gifts ,
Higher Education Act ,
Information Management ,
New Regulations ,
OMB ,
Regulatory Requirements ,
Reporting Requirements
Thanks to the rapid development and widespread acceptance of online programs over the last decade, American universities and their respective business partners now offer degree or non-degree programs entirely online around...more
7/10/2018
/ Accreditation ,
Continuing Education ,
Data Privacy ,
Data Security ,
For Profit Education ,
Global Marketplace ,
Higher Education Act ,
Online Education ,
Regulatory Oversight ,
Regulatory Requirements ,
Tax Liability
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more
5/25/2018
/ Biotechnology ,
Clinical Trials ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
Life Sciences ,
Office for Human Research Protections (OHRP) ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development