On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more
4/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Loper Bright Enterprises v Raimondo ,
Regulatory Reform ,
Rulemaking Process ,
Trump Administration
On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more
Donald Trump will be the 47th President of the U.S. Not since 1892 has a President been elected to two non-consecutive terms, and his victory has helped Republicans pick up several critical seats in Congress. Senate...more
11/8/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Donald Trump ,
Election Results ,
Healthcare ,
Healthcare Reform ,
Lame Duck Session ,
Legislative Agendas ,
Members of Congress ,
Presidential Elections ,
Regulatory Agenda ,
Senate Committees ,
Trump Administration
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
10/31/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Technology Sector ,
Telemedicine
In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide...more
9/1/2023
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Penalties ,
DEA ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Medical Marijuana ,
Schedule I Drugs
Key Takeaways:
The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.
FDA’s recommendations come as part of increasing interest in ensuring clinical...more
4/20/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Black and Minority Ethnic (BME) ,
Clinical Trials ,
Corporate Counsel ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
FDASIA ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Licenses ,
National Institute of Health (NIH) ,
Premarket Approval Applications ,
Sponsors