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
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
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
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 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
12/15/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Cybersecurity ,
Drug Pricing ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC ,
OMB ,
Pending Legislation ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Private Equity ,
Private Equity Firms ,
Resignation ,
Transparency
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.
This week's topics...more
4/24/2023
/ Artificial Intelligence ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
National Cancer Moonshot ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Legislation ,
Public Health Emergency
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.
This week's topics include...more
2/9/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicaid ,
Medicare ,
New Guidance ,
Pending Legislation ,
Pharmacies ,
Public Health Emergency ,
Section 340B ,
State of the Union
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.
This week's topics include: ...more
1/26/2023
/ ACOs ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Committees ,
Congressional Oversight ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare Shared Savings Program ,
National Institute of Health (NIH) ,
Prescription Drugs