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Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more

DOJ Expands Use of the False Claims Act to Target DEI and DEIA Initiatives

On February 5, 2025, Attorney General Bondi issued a Memorandum, “Ending Illegal DEI and DEIA Discrimination and Preferences,” which was designed to implement President Trump’s Executive Order 14173, “Ending Illegal...more

"Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime": DOJ Revises Policies on White-Collar Criminal...

On May 12, 2025, the U.S. Department of Justice’s Criminal Division unveiled an overhaul of its white-collar enforcement policies in a memo issued by Matthew Galeotti, head of the Criminal Division. The memo, titled “Focus,...more

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device... [Audio]

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Gabe Scannapieco, AGG Litigation & Dispute Resolution partner, to discuss enforcement trends affecting foreign...more

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Government Investigations Team Insights - February 2025

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors and federal agency attorneys, has successfully represented...more

Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....more

Q&A With Gabe Scannapieco: Insights From a DOJ Veteran

Q: If you had 30 seconds to describe your practice, what would you say? A: I am a partner in AGG’s Litigation & Dispute Resolution practice, focusing on government investigations, white-collar defense, and commercial...more

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