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Genomics Data Should Get More Attention In FDA Drug Review And Labeling, Regeneron Says

02 Dec 2019

Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.

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Regeneron Pharmaceuticals Inc. is urging the US Food and Drug Administration to use genomic information more broadly in evaluating the safety and efficacy of new drugs and wants the data to be included in product labeling.

The FDA convened a meeting on 7 November to gain stakeholder recommendations on how the Office of New Drugs could...