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Outsourcing Your eCTD Project

Do you need to plan for outsourcing your eCTD project to meet the upcoming FDASIA eCTD mandates for NDAs, BLAs, ANDAs, and INDs?

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Welcome to e-SubmissionsSolutions.com

FDA releases version 3.1 of PDF Specifications
FDA OGD releases updated ANDA checklist for eCTD
FDA releases GDUFA Performance Goals and Procedures mandating eCTD for ANDAs and DMF-II
FDA releases PDF Specification version 3.0
FDA releases PDFUA V Goals and Procedures for FY 2013-2017 mandate eCTD format for NDAs, BLAs and commercial INDs.
PhRMA endorses PDUFA V
BIO endorses PDUFA V goals and procedures
Though outside the scope of PDUFA V, the Generic Pharmaceutical Association announces target agreement in September 2011 for user fees to assure adequate OGD resources to review ANDAs. Is eCTD format for ANDAs the next mandate?

Generic Pharmaceutical Association endorses FDA GDUFA recommendations

IRISS-Forum Introduction

Implementation of Regulatory Information Submission Standards (IRISS) (pronounced ‘Iris’ – the flower) is conceptualized to be a global, open, multidisciplinary, non-profit organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world.

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