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