The FDA's PDF guidance requests that all PDFs are tagged. I have had occasions when either I have received PDFs that are not tagged or had problems rendering files and have had to remove the tagging. How important is it to FDA that PDF files are tagged?

Here is the presentation from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Tuesday, July 21, 2009. If you have any additional questions, please post them to the Forum and a member of Octagon’s Regulatory Affairs Team will respond accordingly.

Is it mandatory to use PIM?

If I submit an MAA via the centralised procedure in eCTD do I still have to submit paper?

I have already submitted an NDA and I’m planning an MAA. What are the key differences from a formatting perspective?

Can I submit promotional material to DDMAC via eCTD?

Where in the eCTD do I put my orphan drug application?

How do organizations handle the 200 character limit of character data in SAS Version 5 when submitting non-CDISC SAS xport files to FDA? Is the automatic truncation of the fields acceptable? Thanks!

The FDA wants companies to use secure email to obtain application numbers.
Here is the link to the latest guidance info:
http://www.fda.gov/cder/regulatory/ersr ... cation.htm

Am I required to submit the electronic application form with eCTD?