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The U.S. Food and Drug Administration (FDA) on Sept. 20, 2025, issued draft guidance, "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," outlining how sponsors can utilize FDA's expedited review...more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Draft Guidance ,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
On July 7, 2025, a coalition of healthcare organizations – including the American Academy of Pediatrics, American College of Physicians and Infectious Diseases Society of America, along with a pregnant Massachusetts physician...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. 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 National Institutes of Health (NIH) issued a notice on June 12, 2025, rescinding recent civil rights–related changes to the terms and conditions governing federally funded research (the Rescission). Effective immediately,...more
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