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ビジネス · 2002/5/171 分で読めます

Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs-In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Withdrawal

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概要

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled "Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies." After careful consideration of the comments from the public and public advisory committees, FDA has decided to withdraw the draft guidance.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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