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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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