eCTD Regulatory Submissions Network Blog providing status updates and discuss on current regulatory trends including eCTD Submissions and best practices in the development and delivery of global dossiers.your comments,feedback and discussion help for all.
06 September 2011
FDA: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 - Draft
FDA releases PDUFA V Goals and Procedures with timeline mandating eCTD for NDAs/BLAs/commercial INDs.
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