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Patents Enforcement Actions Food and Drug Administration (FDA)

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges: Part II

Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

Fish & Richardson on

On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

White & Case LLP

Strong Medicine: Using Investment Treaties to Mitigate Foreign Regulatory Risk in the Life Sciences

White & Case LLP on

The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more

Foley & Lardner LLP

Reading the Leaves: What's in Store for Cannabis in 2021

Foley & Lardner LLP on

On the heels of a year beset by turmoil and the myriad challenges caused by the global pandemic, the cannabis industry nevertheless entered 2021 poised for significant growth amid a landscape teeming with opportunity. Public...more

Holland & Knight LLP

Healthcare Law Update: June 2017

Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

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