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?

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

Latest guidance states that eCRF should be a scanned image of paper CRF including all original entries with all modifications, addenda, corrections, comments, annotations and any extemporaneous additions.

Traditionally, we have submitted the original CRF page as it comes in, and any DCFs for that page, which are linked to the original page. Is this still acceptable, or does FDA want the "working copy" of the CRF page, that has the original entry as well as the handwritten corrections on it, along with the DCF?

When a leaf is submitted, then appended and then replaced... what do you do with the "append?" does it stay out there or do you use the "delete" operator?

When does the EMEA plan to accept eCTAs in eCTD format? I attended the EU EDC DIA conference last week but learned only marketing authorizations will be accepted in eCTD format for the centralized procedure. One of the best ROIs on eCTD for FDA is the "IND becoming the NDA". What is the EMEA's longterm plan for clinical trial applications (Eudract)?