要 約 |
FDA Guidance Document |
FDA Guidance #93 |
規制文書の電子フォーマットでの提出準備 - 連邦食品、医薬品、および化粧品法の第745A条(a)での提出 ![]() Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act ![]() |
Guidance for Industry Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act 規制文書の電子フォーマットでの提出準備 - 連邦食品、医薬品、および化粧品法の第745A条(a)での提出 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Researc(CDER) Center for Biologics Evaluation and Research(CBER) December 2014 Electronic Submission 目次[Table of Contents] Ⅰ.緒論[INTRODUCTION] Ⅱ.背景[BACKGROUND] Ⅲ.FD&C Act第745A条での提出[SUBMISIONS UNDER SECTION 745A(a) OF THE FD&C ACT] A.どんなタイプの提出に、電子提出が要求されるか?[Which submission must be submtted electronically ?] B.どんな提出が、電子提出の要求事項を免除されるか ?[Which submission are exempted form the electronic submission requirments ?] C.FDAは、電子提出の要求事項の権利放棄をするか?[Will FDA issue waivers of the electronic submission requirements ?] D.FDAは、特定の電子提出の要求事項を、どのように実施するか?[How will FDA implement specific electronic submission requirements ?] E.電子提出は、何時要求されるか ?[When will electronic submission berequired ? F.既存のフォーマットへの修正、または更新は何時から有効になるか ? [When will revisions or updates to exixsting formats take effect ?] |