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CDER Updates March/April 2017

 

 

Update to Guidance

Section I. Introduction

• Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

Section III.B. Timetable for Implementation of Electronic Submission Requirements

·         Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.

Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.
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