From: Miriam.Carter@zlbbehring.com
Sent: Thursday, March 10, 2005 3:34 PM
To: fdadockets@oc.fda.gov
Subject: docket 2004N-0535

I realize the comment period is past. However I would like to comment on section B4 on the form. This date is  very confusing and I believe superfluous for drugs and biologics. 

My main reason for writing is to ask if you have any idea when the revised FDA 3500 A form will be mandatory for industry reporting?  Is it to coincide with the release of the revised reporting regulations (The TOME)?  Any time lines on that?

Thank you for your help.

Mimi Carter
Associate Director Pharmacovigilance
ZLB Behring

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