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The FDA issued draft guidance to clarify how the agency evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance.
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We drafted a persuasive binding ruling request and CBP agreed with our classification and issued a binding ruling reflecting the proposed HTS classification. However, Diaz Trade Law’s claim for prior disclosure treatment was successful andno further penalty was assessed by CBP.
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