Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
7/16/2025
/ Biologics ,
Consumer Protection Laws ,
Drug Pricing ,
Enforcement Actions ,
Expedited Approval Process ,
Expedited FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Recalls ,
Proposed Regulation ,
Public Policy ,
Regulatory Agenda ,
Regulatory Reform
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more
The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more
6/19/2025
/ APIs ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Risk Assessment ,
Supply Chain ,
Trump Administration
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
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
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
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
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
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 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
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
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more
1/12/2021
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Response ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Moderna Inc. ,
National Institute of Health (NIH) ,
Operation Warp Speed ,
Pfizer ,
Public Health Emergency ,
State and Local Government ,
Vaccinations
Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more
A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more
11/12/2020
/ Affordable Care Act ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Judicial Appointments ,
Legislative Agendas ,
Presidential Elections ,
Public Policy ,
Regulatory Agenda
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more