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 · 2012/9/251 分で読めます
Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Stability Testing of Drug Substances and Products." FDA is recommending that generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A(R2) through Q1E. The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →