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This Guide provides technical recommendations to sponsors and applicants for the
standardized electronic submission format of INDs, NDAs, ANDAs, BLAs, and master
files. The Guide is intended to complement and promote interactions between sponsors
and applicants and FDA’s electronic submission support staff. However, it is not
intended to replace the need for sponsors and applicants to communicate directly with
support staff regarding implementation approaches or issues relating to electronic
Because of the inherent variability across studies and applications, it is difficult to
identify all issues that may occur related to the preparation and transmission of electronic
submissions. Therefore, prior to submission, sponsors and applicants should discuss
questions with the appropriate center’s electronic submission support staff within the
appropriate center — CDER: esub@fda.hhs.gov or CBER: esubprep@fda.hhs.gov.

Continue at: https://www.fda.gov/media/93818/download

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