
Pharmacovigilence STN 125355/0 Anascorp Email, July 06, 2011 - Anascorp
 

 
Pharmacovigilence STN 125355/0 AnascorpFrom: Menschik, David
Sent: Wednesday, July 06, 2011 10:52 AM
To: Fisher, Robert
Cc: Cordaro, Debbie
Subject: Re: Pharmacovigilence STN 125355/0 Anascorp
Yes we are ok with their response and we are not requiring any postmarketing studies. 
 

From: Fisher, Robert 
Sent: Wednesday, July 06, 2011 10:46 AM
To: Menschik, David 
Cc: Cordaro, Debbie 
Subject: Pharmacovigilence STN 125355/0 Anascorp 
 

Hi David.  Were you OK with RDT/Bioclon's response to your question about their pharmacovigilence plan?  Are there any PMCs that will be required?

Thanks! 
Robert

Robert W. Fisher, Ph.D. 
Staff Fellow, Laboratory of Plasma Derivatives 
FDA/CBER/OBRR/DH 
202-329-3957 
Robert.Fisher@fda.hhs.gov
