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FDA releases PDFUA V Goals and Procedures for FY 2013-2017 mandating eCTD format for NDAs, BLAs and commercial INDs.
PhRMA endorses PDUFA V goals and procedures.
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?
Mandatory electronic submissions are on the horizon. Current estimates are within 3-5 years.
Will you be ready?
February 06, 2012

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