The U.S. Food and Drug Administration (FDA) announced in June 2025 the establishment of a new Commissioner's National Priority Voucher (CNPV) program and began accepting applications, promising those selected an accelerated...more
10/22/2025
/ Administrative Priority ,
Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) on Sept. 20, 2025, issued draft guidance, "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," outlining how sponsors can utilize FDA's expedited review...more
10/6/2025
/ Biologics ,
Biotechnology ,
Clinical Trials ,
Digital Health ,
Draft Guidance ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
Healthcare ,
Real World Evidence ,
Regenerative Medicine ,
Research and Development ,
Sponsors
The U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) on Sept. 9, 2025, announced a broad initiative to "rein in misleading direct-to-consumer pharmaceutical advertisements." In...more
9/30/2025
/ Advertising ,
Cease and Desist ,
Department of Health and Human Services (HHS) ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Misbranding ,
Misleading Statements ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Oversight ,
Telehealth ,
Telemedicine ,
Warning Letters
In accordance with President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212 to create a commission to Make America Healthy Again (MAHA), the Commission released its inaugural report, "The MAHA Report: Making Our...more
9/18/2025
/ Agribusiness ,
Chemicals ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Information Reports ,
Pesticides ,
Public Health ,
Public Policy ,
Regulatory Reform ,
USDA
The Make America Healthy Again (MAHA) Commission was established by President Donald Trump's Feb. 13, 2025, executive order (EO) 14212 titled "Establishing the President's Make America Healthy Again Commission." As Holland &...more
9/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Environmental Protection Agency (EPA) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Information Reports ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Research and Development
The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The...more
The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more
9/8/2025
/ Dental Practice ,
Direct to Consumer Sales ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Laboratories ,
Manufacturers ,
Medical Devices ,
Quality Assurance Programs ,
Regulatory Oversight ,
Regulatory Requirements
A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more
States are rapidly enacting and implementing bans and reporting requirements for per- and polyfluoroalkyl substances (PFAS) in cosmetics, creating a complex and evolving compliance environment for manufacturers, distributors,...more
8/12/2025
/ Cosmetics ,
Distributors ,
Enforcement Actions ,
Hazardous Substances ,
Importers ,
Manufacturers ,
New Legislation ,
Personal Care Products ,
PFAS ,
Popular ,
Regulatory Requirements ,
Reporting Requirements ,
Retailers ,
State Attorneys General ,
State Bans ,
State Legislatures ,
Toxic Chemicals
The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more
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. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more
7/1/2025
/ Chemicals ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
GRAS ,
Proposed Rules ,
Public Health ,
REACH ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Assessment ,
Rulemaking Process ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
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 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
The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone and releasing a number of regulatory actions aimed at enhancing consumer health...more
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
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