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The FDA issued draft guidance to clarify how the agency evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can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 This draft guidance also proposes expanded recommendations to the 2017 guidance.
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In particular, Lawson cites, “downloading forms from databases, saving Word documents as efile-ready PDFs, or inserting a section symbol can slow their progress even while large firms are deploying artificial intelligence to streamline ediscovery workflows.” The bar exam can also include creating a table of authorities or a table of contents.
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. Diaz Trade Law scored a successful win for their client!
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