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Life Sciences › Regulatory Reform › Department of Health and Human Services (HHS)

Mintz - Health Care Viewpoints

FDA in Flux — June 2025 Newsletter

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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

DLA Piper

Make Our Children Healthy Again Assessment: Unpacking the Report

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The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

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What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

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On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more

Jones Day

Executive Orders and Policy Updates

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Since President Trump's inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

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On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

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On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

DLA Piper

Food and Beverage News and Trends - February 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Jim Jones, Deputy Commissioner for Human Foods at the US Food and Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care: Trump Focuses on Drug Pricing Experiments, ACA and Research Grants

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In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

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Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

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Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Hogan Lovells

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

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On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). ...more

Morgan Lewis

UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

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In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

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On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

Hogan Lovells

HHS now requires public posting of a decade of clinical trial results that were previously exempted

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Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

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