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Food and Drug Administration (FDA) Regulatory Requirements Genetic Materials

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

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Cell and gene therapies

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

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