Electronic Submission of New Product Application to the U.S. Food and Drug
Administration
(last updated 2011-02-19)
The next step after capturing and analyzing clinical data is the submission to a
regulatory body for product approval. Clinical data is a part of the submission
package. Like data capture, submission process is also moving toward electronic.
The acceptance of electronic submission is not uniform at the FDA as shown in the
following table. However, all of the centers are moving toward
Regulated Product Submission (RPS) which can be viewed as a new form of
Electronic
Common Technical Document (eCTD)
There are many third party tools helping package submission materials into eCTD
format.