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Xin Tao

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Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and currently heads our US Food and Drug Law Practice. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the US FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing. As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of life science. Xin is a frequent speaker and writer on US FDA legal developments related to emerging technology, and he has been selected to serve on the 2023 Law360 Life Sciences Editorial Advisory Board.
In Product Regulation & Liability

United States: With China’s re-opening: staying ahead of FDA drug cGMP enforcement

by , and 4 Mins Read

The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.

In Product Regulation & Liability

United States: FDA – Zeroing in on lead in food for babies and young children

by , and 3 Mins Read

On 24 January 2023, the US Food and Drug Administration issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age. These action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug & Cosmetic Act. FDA will consider these action levels when determining whether to bring an enforcement action.