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Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney...

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In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Pew poll reveals AI pessimism among American public, AI-assisted treatment found to reduce Parkinson’s symptoms,...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

McDermott+

Coding Update - CPT Editorial Panel Meeting: What’s on the Agenda and Why It Matters

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The American Medical Association (AMA) CPT®1 Editorial Panel will meet in Brooklyn, New York, from May 1 to 3, 2025. The meeting agenda includes proposals to create new current procedural terminology (CPT) codes and to revise...more

Stikeman Elliott LLP

Canada and Manitoba Sign Pharmacare Agreement Under New Pharmacare Act

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Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more

Smart & Biggar

Minister of Health announces new bilateral agreements with provinces for rare disease drugs

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We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more

DLA Piper

“Making America Healthy Again”: The impact on the FDA, life sciences, and healthcare sectors

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President Donald Trump recently issued an Executive Order (EO) establishing the President's Make America Healthy Again (MAHA) Commission. The EO, issued on February 13, 2025, addresses a range of issues, including chronic...more

Benesch

Dialysis & Nephrology Digest - February 2025

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A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

McDermott+

Healthcare Preview for the Week of: February 3, 2025

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The Senate Finance Committee is set to vote on the confirmation of Robert F. Kennedy (RFK) Jr., President Trump’s nominee for Secretary of the US Department of Health and Human Services (HHS), on Tuesday morning. All eyes are...more

Akin Gump Strauss Hauer & Feld LLP

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Alston & Bird

Health Care Week in Review: Congress Races to Avert Government Shutdown; Senators Announce Launch of Make America Healthy Again...

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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

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more

Knobbe Martens

FDA Updates Medical Device Shortages List

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The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Schwabe, Williamson & Wyatt PC

Washington Psilocybin Law Faces Delay

People hoping Washington would closely follow Oregon into the regulated use of psilocybin overseen by licensed practitioners faced a delay when a committee of the Washington legislature converted Senate Bill 5263 from...more

Knobbe Martens

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

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On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

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(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...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

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

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The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

WilmerHale

The Potential Impacts of the Nagoya Protocol on Global Public Health Research

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The State Department is initiating a public process to consider the implications of Access and Benefit-Sharing (ABS) regimes for global health and biomedical research. The Federal Register Notice announcing this initiative...more

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