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King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

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Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

Alston & Bird

Health Care Week in Review: CMS Releases PFS, OPPS, ESRD, and Home Health Final Rules; Senators Cassidy and Hassan Release a...

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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

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

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On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 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

Holland & Knight LLP

Holland & Knight Health Dose: November 7, 2023

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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

Alston & Bird

Health Care Week in Review: CMS Releases Three Major Medicare Final Rules

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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

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

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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

Mintz - Health Care Viewpoints

With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more

King & Spalding

U.S. District Court Overturns HHS Interpretation of Final Rule that Permitted Sponsors of Certain Drug and Device Trials to Avoid...

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If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more

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