Search
Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
Insights and Analysis
18 July 2024
Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation) was yesterday published in the Official Journal...
News
17 July 2024
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how...
News
16 July 2024
The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that...
News
12 July 2024
The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial ...
News
02 July 2024
On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare...
News
29 June 2024
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...
News
28 June 2024
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...
News
27 June 2024
The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small...
News
06 June 2024
In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and...
