Q&A: Lawyer Jeff Gibbs Discusses Implications of Veterinary Drug Case on FDA's LDT, RUO Guidances

Jan 18, 2012

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Originally published Jan. 17.

A federal district court decision in a veterinary drug case may serve as a precedent for those in the life sciences industry who wish to challenge the US Food and Drug Administration's use of guidances to regulate lab-developed tests and the marketing of research-use-only in vitro diagnostic products, a recently issued legal brief suggests.

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