LATEST ARTICLES
United States
Foley & Lardner
Artificial intelligence continues to be one of the most talked about business trends.
J A Kemp LLP
Food systems are responsible for a third of anthropogenic greenhouse gas emissions, and already half of the world's habitable land is devoted to agriculture.
Romano Law
On April 23, 2024, the United States Federal Trade Commission ("FTC") proposed its rule which would ban all new non-compete agreements with virtually all workers.
Outside GC
The U.S. Congress is currently considering legislation to prevent the governments of foreign adversaries from siphoning data and information from U.S. companies...
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.
European Union
Arnold & Porter
The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System, as adopted by the European Medicines Agency on 5 October 2023...
Worldwide
Foley Hoag LLP
New License Exception MED under the Export Administration Regulations ("EAR") authorizes the export, reexport, and/or transfer of EAR99 "medical devices,"...
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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