Transitioning from paper to eCTD for 2253 Submissions?
The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole.
A step in the right direction.
Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency.
By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.