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ビジネス · 2009/2/101 分で読めます

Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal

ローカル自動翻訳 · 情報源の原言語

概要

The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

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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