News & Analysis as of

Food and Drug Administration (FDA) Centers for Medicare & Medicaid Services (CMS) Public Health

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

Alston & Bird

Health Care Week in Review | Congress Passes Recissions Package, CMS Releases CY 2026 PFS and OPPS Proposed 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

McDermott+

McDermott+ Check-Up: March 14, 2025

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THIS WEEK’S DOSE - - Congress Debates Government Funding. A continuing resolution (CR) to fund the government through September passed the House and may pass the Senate today. - Senate HELP Committee Advances NIH, FDA...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

Alston & Bird

Health Care Week in Review | Senate Passes First Budget Resolution; DOJ Opts to Continue Defense in Braidwood SCOTUS Case

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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

Brownstein Hyatt Farber Schreck

White House Establishes MAHA Commission Under Leadership of New HHS Secretary Kennedy

On Feb. 13, moments after Robert F. Kennedy Jr. was confirmed as secretary of health and human services, President Donald Trump issued his first health care Executive Order (EO) under new leadership, laying the groundwork to...more

Alston & Bird

Health Care Week in Review: OMB Issues and Rescinds Memo Freezing Federal Funds; Senate Finance and HELP Committees Hold HHS...

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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

King & Spalding

HHS Acting Secretary Fink Issues Memo to Pause Federal Health Communications

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On January 21, 2025, according to a memo made available by news outlets, Acting Secretary of HHS, Dr. Dorthy Fink, issued a memo directing the agency’s operating divisions to refrain from most external correspondence,...more

Alston & Bird

Health Care Week in Review: Donald Trump Wins 2024 Presidential Election; Republicans May Control Both Senate and House of...

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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

Alston & Bird

Health Care Week in Review: HHS Released Final Guidance for the Second Cycle of Medicare Drug Price Negotiations; CMS Released...

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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

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 Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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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

Goodwin

FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot

Goodwin on

The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase...more

Holland & Knight LLP

Holland & Knight Health Dose: October 4, 2022

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

Goodwin

Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation

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Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

Alston & Bird

Alston & Bird Health Care Week in Review - May 2021 #1

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

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #2

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

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 10

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In Washington: State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they lack enough money to carry out the immense...more

Alston & Bird

Alston & Bird Health Care Week in Review - August 2020 #4

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

Foley & Lardner LLP

COVID-19: Ten Things to Know about Laboratory Testing

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Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more

Foley & Lardner LLP

Improving 21st Century Cures Act: Personalized Medicine and COVID-19

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On April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #15

Congress, Administration Reach $484 Billion Deal for Phase 3.5 - Yesterday, congressional Democrats and Republicans reached a $484 billion deal with the Trump Administration for “Phase 3.5” of the coronavirus response to,...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #14

President Trump Unveils Framework for “Opening Up America Again” - President Trump yesterday provided recommendations to governors for reopening parts of the U.S. economy. The guidance, dubbed “Opening Up America Again,”...more

Patrick Malone & Associates P.C. | DC Injury...

Congress approves 650-page bill to attack opioid crisis, as doubts abound

Congress has approved a major new push to deal with the opioid crisis that kills tens of thousands of Americans annually. Voters can expect President Trump to sign the big bill, passed easily and with rare bipartisan support...more

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