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
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. 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
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
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
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
As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more
1/7/2022
/ Affordable Care Act ,
Appropriations Bill ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Coronavirus/COVID-19 ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Graduate Medical Education ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Industry Consolidation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
NDAA ,
Proposed Legislation ,
Public Health ,
Public Health Emergency ,
Surprise Medical Bills ,
Telehealth ,
Water Resources Development Act
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
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more
Note -
On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
1/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Agricultural Sector ,
Appropriations Bill ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Drug Approvals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Popular
Alex Azar, a former executive of Eli Lilly was nominated by President Trump today to be Secretary of the Department of Health and Human Services (HHS). Azar would replace former Secretary Tom Price who resigned amid an ethics...more