News & Analysis as of

Food and Drug Administration (FDA) Health Care Providers

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

Benesch

CMS Proposes Overhaul of Skin Substitute Reimbursement Policy Beginning January 2026 - Implications for Providers, Manufacturers,...

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On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more

White & Case LLP

Life Science & Healthcare Private Equity Risk: Q2 2025 Update

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Private capital firms focused on investment and operations within the Life Science and Healthcare industries face complex compliance, operational, and business risks. To help clients navigate this evolving environment, White...more

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-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

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Alston & Bird

Health Care Week in Review | House Ways & Means Committee Holds Hearing on Medicare Advantage; President Trump Signs Executive...

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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

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

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As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Alston & Bird

Health Care Week in Review | Senate Parliamentarian Issues Rulings on Budget Reconciliation Provisions; Supreme Court Upholds the...

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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

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

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For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Alston & Bird

Health Care Week in Review | Senate Finance Committee Releases Budget Reconciliation Text; SCOTUS Upholds TN Ban on...

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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 | 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

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

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On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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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

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

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FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Alston & Bird

Health Care Week in Review | House Passes Budget Reconciliation Package; MAHA Commission Releases Childhood Chronic Disease Report

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #2

News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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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

DLA Piper

DOJ Memo Identifies False Claims Act and Enforcement Risks Related to Gender Transition Medication and Procedures

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Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more

Alston & Bird

Health Care Week in Review | President Trump Unveils FY 2026 Discretionary Budget Request; Budget Reconciliation Negotiations in...

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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

Burr & Forman

The FDA Removes Semaglutide from the Drug Shortage List

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The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more

Alston & Bird

Health Care Week in Review | Senate HELP Committee Chair Cassidy Calls for 340B Reforms; House Republicans Launch American-Made...

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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

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

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