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Department of Health and Human Services (HHS) Public Health Pharmaceutical Industry

Akin Gump Strauss Hauer & Feld LLP

Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve (Trump...

The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical...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...

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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

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

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #1

News Briefs - Hospital, Device Makers Seeking Exemptions on Tariffs - Medical device makers, hospitals, and other key health industries are pressing to gain exemptions under the Trump administration's new tariff regime with...more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

Faegre Drinker Biddle & Reath LLP

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

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

Faegre Drinker Biddle & Reath LLP

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

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Holland & Knight Health Dose 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

Holland & Knight LLP

Holland & Knight Health Dose: February 19, 2025

Holland & Knight LLP on

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

Faegre Drinker Biddle & Reath LLP

A Deeper Dive Into the Making America Healthy Again Commission’s Executive Order and Its Implications

On February 13, 2025, shortly after Robert F. Kennedy, Jr., was confirmed by the U.S. Senate as secretary of Health and Human Services, President Donald Trump issued an executive order establishing the Make America Healthy...more

Hogan Lovells

JPM panelists see opportunities under new U.S. regulators for venture capital and investing in emerging life sciences fields

Hogan Lovells on

The outcome of the 2024 U.S. election had far-reaching implications for the global investment landscape, especially in the dynamic field of venture capital and early-stage investing. Speaking at the J.P. Morgan Healthcare...more

Skadden, Arps, Slate, Meagher & Flom LLP

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Health Care Compliance Association (HCCA)

Rob DeConti on the Latest Guidance and Insights from the OIG at HHS

In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...more

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

McDermott Will & Schulte

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Wilson Sonsini Goodrich & Rosati

FDA Prioritizes Review Generic Drug Products to Treat Opioid Overdose

Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more

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