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Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

Morgan Lewis - As Prescribed on

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

Sheppard Mullin Richter & Hampton LLP on

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

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

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

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

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Harris Beach Murtha PLLC

Division Y-Cyber Incident Report for Critical Infrastructure Act of 2022 Becomes Law, with Regulations Expected by 2025

Harris Beach Murtha PLLC on

Division Y – Cyber Incident Reporting for Critical Infrastructure Act of 2022 was signed into law by President Biden on March 15. Highlights of the Act include: ...more

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

McDermott Will & Schulte

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

McDermott Will & Schulte on

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Troutman Pepper Locke

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper Locke on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

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