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Clinical research / Clinical Data Management / Pharmaceutical industry / Medical informatics / Electronic Common Technical Document / Common Technical Document / Title 21 CFR Part 11 / Electronic submission / Center for Biologics Evaluation and Research / Food and Drug Administration / Medicine / Research


SOPP 8422: Processing of Trans-BLA Submissions Version #1 Effective Date: April 18, 2011 I. Purpose The purpose of this document is to provide guidance to Center for Biologics Evaluation and
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Facility

Document Control Center / CBER's Document Control Center / /

IndustryTerm

product applications / harmonized technical solution / Web portal / Internet Web page / /

Organization

FDA / B. Document Control Center / CBER's EDR / CBER’s DCC / CBER's Document Control Center / CBER’s EDR / Center for Biologics Evaluation and Research / /

Position

appropriate Electronic Submission Coordinator / Responsibilities A. Product Office Regulatory Project Manager / General / C. Electronic Submission Coordinator / /

Product

M-16 / /

ProgrammingLanguage

XML / /

Technology

DTD / XML / Extensible Markup Language / Document Type Definition / PDF / /

URL

http /

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