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 U.S. Department of Commerce announced that it has initiated a Trade Expansion Act of 1962 Section 232 investigation to determine whether imports of pharmaceutical products and ingredients pose a national security risk to...more
4/17/2025
/ Comment Period ,
Countermeasures ,
Executive Orders ,
Government Investigations ,
Imports ,
National Security ,
Pharmaceutical Industry ,
Public Comment ,
Section 232 ,
Supply Chain ,
Tariffs ,
Trade Expansion Act of 1962 ,
Trade Policy ,
Trump Administration ,
U.S. Commerce Department ,
US Trade Policies
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
4/9/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Executive Orders ,
Federal Budget ,
Federal Grants ,
Healthcare ,
Legislative Agendas ,
MACPAC ,
Medicare ,
Medicare Part D ,
MedPAC ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Agenda ,
Tariffs ,
Trump Administration
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
Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
2/26/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
Tariffs
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
2/20/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
DEA ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Agenda ,
Senate Confirmation Hearings