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 · 2021/9/81 分で読めます
Center for Drug Evaluation and Research Office of New Drugs Novel Excipient Review Pilot Program
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing a Novel Excipient Review Pilot Program (Pilot Program). The Pilot Program is voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →