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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
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The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...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The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...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
Over the last six months, the U.S. Department of Justice (DOJ) has remained vigilant in pursuing cybersecurity-related fraud under its Civil Cyber-Fraud Initiative first announced in...
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...
News
06 May 2024
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...
News
18 April 2024
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...
News
02 April 2024
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...
Insights and Analysis
29 March 2024
Advancements in medical technology make healthcare and radiopharmaceutical companies attractive investment prospects. And we are seeing this interest in real time. However, acquiring...
