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Life Sciences Enforcement Priorities Pharmaceutical Industry

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Fenwick & West LLP

CLE Takeaways: 2025 Life Sciences M&A Trends

Fenwick & West LLP on

While life sciences M&A activity surges in today’s markets, the shift in regulatory enforcement priorities, constant innovation in technology, and strategic growth opportunities are changing the way dealmakers are approaching...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q1 2023

Goodwin on

Our prior updates covered how FTC enforcement activity largely proceeded “as usual” during 2022 in the life sciences industry, with large pharmaceutical players buying or licensing promising, but still risky, assets from...more

Hogan Lovells

Unapproved stem cell therapies remains a top FDA enforcement priority

Hogan Lovells on

Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more

Skadden, Arps, Slate, Meagher & Flom LLP

Will FDA and DOJ Reassert Their Enforcement Muscle With Life Sciences in 2022?

Takeaways - Despite predictions that the Biden administration would devote increased enforcement resources to the life sciences industry broadly, so far, the FDA and DOJ have focused their efforts on COVID-related conduct. ...more

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