FDA Issues Draft Guidance Affecting Personalized Biologics

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On July 14, the FDA issued a new draft guidance concerning in vitro companion diagnostic devices (“IVD companion diagnostic devices”). As explained in its press release, such IVD companion diagnostic devices are already in use to identify patients that are most likely to benefit from certain therapeutic products, such as some monoclonal antibodies.

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Published In: Administrative Agency Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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