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 · 2002/4/91 分で読めます
Draft Guidance for Industry on IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products." This guidance clarifies FDA's policy on exemption from investigational new drug (IND) application requirements for studies of marketed cancer drug or biological products. This guidance is intended to decrease the burden to investigators and regulators of submitting unnecessary IND applications.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →