Coronavirus/COVID-19, Drug Pricing

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Morgan Lewis - As Prescribed on 6/10/2025

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Trump Administration Executive Order Tracker

McDermott+ on 5/12/2025

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

Navigating the Health Care Impacts of President Trump's First Executive Actions

Brownstein Hyatt Farber Schreck on 1/30/2025

Since taking office for his second term on Jan. 20, 2025, President Donald Trump has issued a series of executive orders (EOs) aimed at undoing several health care policies implemented by the Biden administration, indicating...more

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

King & Spalding on 12/11/2024

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

2024 End-of-Year Plan Sponsor “To Do” List (Part 1) Health and Welfare

Snell & Wilmer on 11/15/2024

We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate SW Benefits Updates. This Part 1 covers year-end health and welfare plan issues. Parts 2,...more

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

Ropes & Gray LLP on 11/5/2024

Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Healthcare Authority Newsletter - May 2024 #2

Arnall Golden Gregory LLP on 5/13/2024

News Briefs - Groups Urge Appeals Court to Revive Drug Price Negotiation Suit - Healthcare and drug industry groups urged a U.S. appeals court to revive their challenge to a law requiring manufacturers to negotiate the prices...more

Key Takeaways From the 2024 J.P. Morgan Healthcare Conference

Ballard Spahr LLP on 1/22/2024

Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more

Regulatory Reflections from the Past Year

McDermott+ on 12/21/2023

As 2023 comes to a close, I can’t help but reflect on all the regulations and policies we reviewed this year (and those that we’ll continue to handle next week before the year actually ends). There were some tasty eggs with...more

The 340B Drug Pricing Paradox

Holland & Knight LLP on 11/9/2023

The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

Robinson+Cole Health Law Diagnosis on 10/30/2023

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

2023 End-of-Year Plan Sponsor “To Do” Lists (Part 1) Health and Welfare

Snell & Wilmer on 10/12/2023

We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more

Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

Alston & Bird on 9/6/2023

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

Better Health Care Newsletter - September 2023

Patrick Malone & Associates P.C. | DC Injury... on 9/5/2023

Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more

10 Health Issues to Watch as Congress Returns from August Recess

Akin Gump Strauss Hauer & Feld LLP on 9/1/2023

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Life Sciences Landscape: 2023 Mid-Year Industry Update

Ballard Spahr LLP on 7/21/2023

The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...more

Holland & Knight Health Dose: May 16, 2023

Holland & Knight LLP on 5/19/2023

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

McDermottPlus Check-Up: May 5, 2023

McDermott+ on 5/8/2023

The House held a district work week while the Senate was in session, with plenty of healthcare action at the committee level. The Senate Finance Committee held a hearing on barriers to mental health care. The Senate Health,...more

Healthcare Preview for the Week of: May 1, 2023

McDermott+ on 5/1/2023

Lots of Healthcare Activity in Congress - Activity in Congress focusing on healthcare issues has increased over the last few weeks and is not slowing down anytime soon. This week, the Senate Health, Education, Labor, and...more

Holland & Knight Health Dose: March 28, 2023

Holland & Knight LLP on 3/30/2023

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 Health Dose: March 14, 2023

Holland & Knight LLP on 3/15/2023

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. This week's topics include ... ...more

Holland & Knight Health Dose: January 31, 2023

Holland & Knight LLP on 2/2/2023

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. This week's topics include:...more

Holland & Knight Health Dose: January 24, 2023

Holland & Knight LLP on 1/26/2023

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. This week's topics include: ...more

Hot Topics in Health Care January 2023

Burr & Forman on 1/18/2023

Court Remands Remedy for Unlawful 340B Rule to HHS - On January 10, 2023, the DC District Court remanded the issue of how to remedy five years of underpayments to 340B hospitals to the Department of Health and Human...more

Day 4 Notes from the 41st Annual J.P. Morgan Healthcare Conference

Sheppard Mullin Richter & Hampton LLP on 1/16/2023

One of the topics I followed with keen interest this week at the J.P. Morgan Healthcare Conference is how our healthcare industry today is addressing the mental health needs of Americans. Like much of the rest of healthcare,...more

Coronavirus/COVID-19 › Drug Pricing

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