Partner Michele Buenafe is quoted in BioWorld discussing the potential challenges to US Food and Drug Administration (FDA) actions following the US Supreme Court’s decision to overrule the Chevron doctrine. Michele said one area that could be up for legal challenge is the FDA’s guidance for clinical decision software (CDS).
She noted that the CDS guidance highlights the issues that crop up when a statute does not empower an agency to fill in statutory gaps via regulation or guidance.
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