LATEST ARTICLES
United States
Kramer Levin Naftalis & Frankel LLP
President Biden signed the Inflation Reduction Act (IRA) into law on Aug. 16, 2022, with the goal of reducing health care costs for the government and participants...
Axinn Veltrop & Harkrider
As discussed in November and December, the FTC has placed improper Orange Book patent listings squarely in its crosshairs. Initially, based on its September 2023 policy statement...
Holland & Knight
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule...
Mintz
Of Counsel Benjamin Zegarelli spoke with MD+DI on the FDA's updated regulations to classifying laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act...
Crowell & Moring LLP
Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk
Sheppard Mullin Richter & Hampton
Yesterday, the Food & Drug Administration ("FDA" or "the Agency") issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year...
Goodwin Procter LLP
On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs).
Foley & Lardner
On April 23, 2024, the U.S. Federal Trade Commission (FTC or "Commission") finalized a rule, by a vote of 3-2, abolishing the vast majority of employee covenants not to compete across...
Goodwin Procter LLP
On April 23, 2024, Alvotech announced "positive topline results from a confirmatory clinical study for AVT05," Alvotech's proposed golimumab biosimilar to Janssen Biotech, Inc.'s...
Kramer Levin Naftalis & Frankel LLP
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...
Bass, Berry & Sims
While healthcare mergers and acquisitions activity in the physician practice management (PPM) and hospital sectors appears to have slightly ticked up in Q1 compared to the last quarter of 2023...
Duane Morris LLP
The USPTO is soliciting comments regarding its proposed fee increases for fiscal year 2025. Written comments must be received on or before June 3, 2024, to ensure consideration.
Buchanan Ingersoll & Rooney PC
Recent reports from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have brought to light a concerning development for those in the aesthetic...
Venable LLP
According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab).
Foley & Lardner
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage...
Marshall, Gerstein & Borun LLP
The IPO Law Journal recently published a paper titled "Patent Marking Regarding Software Medical Devices." The paper discusses an overview of patent marking-related case law...
Jones Day
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions.
Foley & Lardner
Foley's clients entrust our firm to look beyond the law to deliver holistic business solutions for their most challenging problems.
Worldwide
Arnold & Porter
On April 10, 2024, the European Parliament (EP) voted on its amendments to the European Commission's (EC) July 4, 2023 proposal for a GDPR Enforcement Regulation (the Proposal).
Arnold & Porter
This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2024 from the United States, United Kingdom, and European Union.
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