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New Guidance Enforcement Actions Life Sciences

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....more

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Jones Day

DOJ Civil Division Gives Clarity on “Inability-to-Pay” Determinations in the Midst of Ongoing Pandemic

Jones Day on

The Situation: Companies facing the twin prospects of a significant Department of Justice ("DOJ") settlement and financial distress have historically had little insight into how the DOJ evaluates an assertion by a company...more

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