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Wed, 07/18/2007 - 05:12

My First Blog

So, suffice it to say, I am approaching 50 years old and thus have never blogged before, but the idea was planted last year at an industry award dinner when I was seated at a table with the award winning blogger, who blogged about fashion, and was about my age. So, I figured (as I have with everything from regulatory submissions to parenting), if she can do it so can I!

Here goes . . . who am I?

Preassigned application numbers

Submitted by nsmerkanich on Tue, 05/20/2008 - 18:34.

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

FDA Form 3674/clintrial.gov

Submitted by nsmerkanich on Tue, 05/20/2008 - 18:33.

FDA told us to put as a separate leaf with the cover letter in M1.2 for those submissions that require it. This is not in the eCTD spec nor will it be any time soon!
For more info on how to use the form check out:
http://www.fda.gov/oc/initiatives/fdaaa ... tions.html

eCTD and Smart Forms

Submitted by nsmerkanich on Tue, 05/20/2008 - 18:23.

Check out this presentation, as well as the Forms page at FDA:
http://www.fda.gov/cder/regulatory/ersr ... dation.pdf
http://www.fda.gov/opacom/morechoices/f ... forms.html