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 · 2019/8/151 分で読めます
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Guidance for Industry; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." The purpose of this guidance is to provide recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies regulated by the Center for Drug Evaluation and Research) intended for the treatment of osteoporosis.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →