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Food and Drug Administration (FDA) Department of Health and Human Services (HHS) Pharmaceutical Industry

Blank Rome LLP

Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?

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The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more

Venable LLP

The Return of CBER Director Prasad, FDA Announces New Chief Counsel, and FDA Budget Watch

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In our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or the Agency) that may affect the Agency′s structure and stakeholder interactions. ...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

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Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott+

Trump Administration Executive Order Tracker

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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

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

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On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Holland & Knight LLP

FDA Announces "National Priority Voucher" Program to Accelerate Reviews of New Drugs

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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

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

Paul Hastings LLP

Biotech Spin-Off Transactions

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As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....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

Knobbe Martens

Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

Knobbe Martens on

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans...more

McDermott Will & Schulte

Navigating Political Waves and Policy Shifts - European Health & Life Sciences Symposium 2025

In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available...more

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

Ropes & Gray LLP

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

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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

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Goodwin

President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs

Goodwin on

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs.  On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

DLA Piper

President Trump Signs Executive Order Aimed at Reducing Prescription Drug Prices

DLA Piper on

President Donald Trump signed an Executive Order (EO) titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at reducing prescription drug prices for Americans by ensuring they do not pay...more

Goodwin

Most Favored Nation Drug Pricing Executive Order Resurrects Prior President Trump Policy

Goodwin on

On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more

Baker Donelson

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

Baker Donelson on

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

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

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