Deficiencies Email, January 19, 2011 - EVARREST

From: Barash, Faith
Sent: Wednesday, January 19, 2011 1:49 PM
To: Kelly, Sonday
Subject: Deficiencies

Hi Sonday,
Since I look only at pharmacovigilance, I generally only have to say whether there is or is not a pharmacovigilance plan submitted prior to my review.  As they do have a pharmacovigilance plan in place, do I need to submit a memo stating that there is no deficiency?  It seems a little redundant.  I would think that a memo is required only if there is a deficiency, so letter comments can be put in place.  If there is no deficiency, then there is really nothing to say.
Thanks
Faith

Faith Barash, MD MPH FACOG
FDA Center for Biologics Evaluation and Research
Therapeutics and Blood Safety Branch
Division of Epidemiology, Office of Biostatistics and Epidemiology
WOC1, Room 438S
1401 Rockville Pike
Rockville, MD 20852
301-827-6081
 
