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Recent Federal and State Initiatives Addressing Food Safety: MAHA Commission Driving Significant Changes in Food and Beverage...

The food and beverage industries are seeing a fast-changing regulatory landscape at both the federal and state levels. These efforts are being driven primarily by the US Department of Health and Human Services (the “HHS”),...more

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

DOJ Civil Division Announces Five Enforcement Priorities

On June 11, 2025, in a memorandum entitled Civil Division Enforcement Priorities (the “Memo”), the Department of Justice (DOJ) Civil Division outlined its five priority areas for investigations and enforcement actions: (1)...more

HHS and FDA Announce Plans to Phase out Synthetic Food Dyes

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food...more

US FTC Continues Aggressive Scrutiny of Pharmaceutical Patents Listed in the Orange Book

On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of...more

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