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FDA Submission Clock Ticking For Standardized Electronic Study Data

 
• By Sarah Karlin-Smith

Binding final guidance says refuse-to-file or refuse-to-receive actions will be taken if NDAs, BLAs or ANDAs contain study data that don’t conform to new standards that take effect starting in December 2016.

Study data from clinical trials and nonclinical research that start on or after Dec. 18, 2016 must be given to FDA in standardized electronic format in NDAs, ANDAs and certain BLA submissions or face a refuse-to-file or refuse-to-receive notice from the agency.

Certain IND submissions will have an additional year before electronic standardized data must be given to FDA. For studies that start on Dec. 18, 2017 or later, sponsors will need...

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