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 · 2014/4/231 分で読めます
Guidance for Industry on Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations." The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →