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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.