News & Analysis as of

Food and Drug Administration (FDA) Biden Administration Healthcare Reform

Holland & Knight LLP

Holland & Knight Health Dose: June 10, 2025

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The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more

Alston & Bird

Health Care Week in Review | CMS Rescinds Biden-Era EMTALA Abortion Guidance; CBO Projects 16 Million Could Lose Coverage Under...

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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

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

Polsinelli on

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Akin Gump Strauss Hauer & Feld LLP

Cures 2.0, A Deeper Dive on ARPA-H and MCIT as Congress Considers Accelerating Innovation from Bench to Bedside

Background on Cures 2.0 - The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

Morgan Lewis

How a Biden Administration Will Affect FDA’s Regulation of Medical Devices

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Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more

Mintz - ML Strategies

Post-Election 2020 - Health Care Preview

Mintz - ML Strategies on

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy. President-elect Biden has been clear that he wants to...more

Holland & Knight LLP

Healthcare Policy Update: Election Edition

Holland & Knight LLP on

A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more

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