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Regulatory Reform Regulatory Requirements Department of Health and Human Services (HHS)

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

McDermott+ on

Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

McDermott+

Health Information Technology Policy Under the Trump Administration

McDermott+ on

Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Mintz - Health Care Viewpoints

FDA in Flux — June 2025 Newsletter

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Mayer Brown

HHS and FDA Announce Plans to Phase out Synthetic Food Dyes

Mayer Brown on

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food...more

Morgan Lewis - ML Benefits

Executive Order Targets Prescription Drug Pricing: Potential Impact on Group Health Plans

President Donald Trump issued an executive order (EO) on May 12, 2025 to address the high cost of prescription drugs in the United States with the goal of ensuring Americans have access to most-favored-nation (MFN) pricing,...more

Woodruff Sawyer

​​​​​​Agencies Push Pause Button on Enforcement of MHPAEA 2024 Final Rule

Woodruff Sawyer on

On May 15, 2025, the Department of Labor, Department of Health and Human Services, and the Treasury Department (collectively, the “Agencies”) released a statement regarding the Agencies’ recent request for abeyance of a...more

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

Seyfarth Shaw LLP on

On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Morgan Lewis - ML Benefits

US District Court Grants Freeze on Mental Health Parity Enforcement

The US Departments of Health and Human Services, Labor, and the Treasury (together, the Departments) filed a motion to suspend the litigation proceedings in The ERISA Industry Committee vs. HHS et al. on May 9, 2025 while the...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

King & Spalding on

On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

McDermott+

The First 100 Days: By the Numbers

McDermott+ on

To state the obvious, a lot has happened in healthcare over the first 100 days of President Trump’s second term. But how much? ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

Hogan Lovells

HHS and FDA Announce Plans to Phase Out Certified Colors

Hogan Lovells on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more

Morrison & Foerster LLP

FDA Seeks to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more

DLA Piper

President Trump Signs Executive Order to Lower Prescription Drug Costs

DLA Piper on

President Donald Trump recently signed an Executive Order (EO) aimed at lowering the cost of prescription drugs, titled, “Lowering Drug Prices by Once Again Putting Americans First.” On April 15, 2025, through this EO, the...more

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Morgan Lewis on

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

Hogan Lovells

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

Hogan Lovells on

Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more

Baker Donelson

What Food and Beverage Manufacturers Should Be Considering With HHS Secretary Kennedy at the Reins

Baker Donelson on

Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...more

ArentFox Schiff

Top 10 Issues in the Cannabis Industry for 2025

ArentFox Schiff on

It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

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