FDA plans to put out separate guidances specifying the electronic format for certain types of submissions under NDAs, ANDAs, BLAs, and the final versions of these individual guidances will start the clock on when sponsors will be required to submit those specific submissions in electronic format.
FDA Electronic Submission Deadlines Becoming Pixilated
Mandated electronic submissions likely to be staggered as agency says it’s not feasible to describe and implement electronic formats that apply to all submissions in one guidance.
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