Source: Regxia Blog

Regxia Blog It's here! CDER and CBER will only accept eCTD for new NDAs, ANDAs, and BLAs.

In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone represents a substantive step forward in the agencies ... Continue reading →

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Betty A. Cory's photo - President of Regxia

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Betty A. Cory

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