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Export Controls Food and Drug Administration (FDA) Regulatory Requirements

Katten Muchin Rosenman LLP

FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

WilmerHale

BIS Increases Export Controls on Key Biotech Equipment

WilmerHale on

On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. ...more

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