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ビジネス · 2012/6/141 分で読めます

Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications

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概要

The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES).

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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