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Wednesday, 23 April 2025

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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

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GlobalSubmit REVIEW and VALIDATE software for the FDA and for Life Sciences organizations around the world. Click here...

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