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The Record
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Orange and Purple Book dates, derived with their rule
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Orange Book, Drugs@FDA and Purple Book as one record
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Every 510(k), De Novo and PMA decision, dated: PMA data use, patent term extension, Medicare
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510(k), De Novo and PMA decisions, screened for AI
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Medicare codes, NTAP and pass-through, tied to FDA authorizations
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What an authorization obliges, and when
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Every statute and regulation cited, verbatim
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