The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more
5/27/2025
/ Artificial Intelligence ,
Chemicals ,
Clinical Trials ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Information Reports ,
Pesticides ,
Prescription Drugs ,
Public Health ,
Regulatory Reform ,
Toxic Chemicals ,
Trump Administration
The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more
5/23/2025
/ Chemicals ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
FIFRA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Proposed Rules ,
Proposition 65 ,
Public Comment ,
Regulatory Oversight ,
Regulatory Reform ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more
The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more
4/25/2025
/ ADEA ,
Anti-Discrimination Policies ,
Civil Rights Act ,
Department of Health and Human Services (HHS) ,
Diversity and Inclusion Standards (D&I) ,
Executive Orders ,
Federal Funding ,
Federal Grants ,
Government Agencies ,
Grants ,
National Institute of Health (NIH) ,
Proposed Rules ,
Regulatory Requirements ,
Rehabilitation Act ,
Title IX
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more
The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more
Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
2/11/2025
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Grants ,
Healthcare ,
Life Sciences ,
Medical Research ,
National Institute of Health (NIH) ,
Public Health ,
Research Funding ,
Scientific Research
Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more
2/4/2025
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Safety ,
Food and Drug Administration (FDA) ,
National Institute of Health (NIH) ,
Presidential Nominations ,
Public Health ,
Regulatory Agenda ,
Senate Confirmation Hearings ,
Vaccinations
Holland & Knight's Healthcare & Life Sciences Policy Team regularly provides updates through our weekly Health Dose. This special Health Dose: Post-Election Edition is intended to outline the short- and long-term potential...more
11/12/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Intent ,
Election Results ,
Federal Budget ,
General Elections ,
Health Care Providers ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
NDAA ,
Political Parties ,
Presidential Elections ,
Public Policy
President-Elect Donald Trump is poised to expand upon policies he implemented during his first term in office, such as those emphasizing limited government, states' rights and lower taxes. Additionally, it is anticipated that...more
11/8/2024
/ Affirmative Action ,
Affordable Care Act ,
Canada ,
Centers for Disease Control and Prevention (CDC) ,
Climate Change ,
Critical Infrastructure Sectors ,
DACA ,
Defense Sector ,
Deregulation ,
Educational Institutions ,
Election Results ,
Energy Policy ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Foreign Policy ,
Immigration Procedures ,
Income Taxes ,
Mexico ,
National Institute of Health (NIH) ,
NATO ,
Public Health ,
Public Schools ,
SALT ,
Tariffs ,
Tax Credits ,
Tax Cuts and Jobs Act ,
Title IX ,
Transportation Industry ,
Trump Administration ,
US Trade Policies ,
USDA ,
Veterans
The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more
Recent congressional activity highlights the changing environment for cannabis regulation. Specifically, U.S. Congress is moving forward with legislation that will change the regulation of hemp-derived products. The industry...more
7/29/2024
/ Appropriations Bill ,
Cannabis Products ,
Congressional Committees ,
Controlled Substances Act ,
DEA ,
Department of Agriculture ,
Farm Bill ,
Hemp ,
Proposed Amendments ,
Proposed Legislation ,
THC ,
USDA
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
In this episode of "The Eyes on Washington Podcast," Public Policy & Regulation attorneys Michael Werner, Sara Klock, Joshua Odintz and Ed Perlmutter discuss the proposed rule by the U.S. Drug Enforcement Administration (DEA)...more
The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more
In the latest episode of Holland & Knight's Public Policy & Regulation Group "Eyes on Washington" podcast series, Healthcare & Life Sciences attorney Michael Werner and Sara Klock examine pivotal shifts in U.S. Food and Drug...more
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more
In this episode of the "Eyes on Washington" podcast series by Holland & Knight's Public Policy & Regulation Group, Healthcare and Life Sciences attorneys Michael Werner and Sara Klock discuss recent developments in marijuana,...more
The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more
The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more
The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow...more