この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2011/9/11 分で読めます
Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability
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概要
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "PET Drug Applications--Content and Format for NDAs and ANDAs." This document is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
情報源の原言語: Federal Register — Health and Human Services原文の発表を開く →