FDA CDER Processing an Electronic NDA

“Processing an Electronic New Drug Application” CDER Office of Review Management. Policy and Procedure Manual MAPP 7600.7

This MAPP describes the procedures involved in processing an electronic new
drug application (NDA).

An applicant can submit some or all of the archival copy of an NDA in electronic
format. This MAPP describes the steps for processing an NDA with an electronic
component.

SoftwareCPR keywords: submissions

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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