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Medicare Regulatory Reform Food and Drug Administration (FDA)

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Ropes & Gray LLP

Executive Order Calls for Most-Favored-Nation Pharmaceutical Pricing for American Patients

Ropes & Gray LLP on

On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more

Skadden, Arps, Slate, Meagher & Flom LLP

President Trump Issues Executive Order Intended To Lower Drug Prices

On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more

Akin Gump Strauss Hauer & Feld LLP

Lowering Drug Prices by Once Again Putting Americans First (Trump EO Tracker)

This order makes it the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at a lower cost to...more

Mintz - Health Care Viewpoints

HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more

McDermott+

HHS’s Restructuring: What Happens Next?

McDermott+ on

Last week, the US Department of Health and Human Services (HHS) announced that it will undergo a major restructuring and plans to eliminate 10,000 employees on top of 10,000 HHS employees who have already departed (20,000...more

McDermott+

McDermott+ Check-Up: February 21, 2025

McDermott+ on

Senate Passes Budget Resolution. Last week, the Senate and House Budget Committees each passed separate, and very different, budget resolutions as their first steps toward negotiating a unified budget resolution that must...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

Jones Day on

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

Holland & Knight LLP

Holland & Knight Health Dose: May 14, 2024

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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

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