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 · 2003/9/151 分で読めます
Guidance for Industry on Investigational New Drug Application Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer; 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 "IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer." This guidance clarifies FDA's policy on exemption from investigational new drug application (IND) requirements for studies of marketed cancer drug or biological products. This guidance is intended to decrease the submission of unnecessary IND exemptions.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →