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 · 2013/5/21 分で読めます
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program
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 a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →