
First Committee Meeting Minutes, December 22, 2012 - Bivigam


 
 

Date:         December 22, 2010                                  

 

From:        Pratibha Rana

 

To:             STN 125389/0

 

Re:             First Committee Meeting Minutes

________________________________________________________________________

 

Date November 23, 2010

Location: WOC -1

Time: 3:00-4:00pm

 

Attendees: Michael Kennedy, Harold Boxenbaum, Mitchell M Frost, Lillian Ortega, Alan C Ou, Evi Struble, Lilin Zhong, Douglas Frazier, Maria Luisa Virata, Malgorzata Mikolajczyk, Pei Zhang,  Jessica Kim, Sonday Kelly, and Pratibha Rana

 

I updated the review team of the review schedule. I also notified that the Sponsor was requested to submit the entire PNR request to the BLA.

 

The purpose of this meeting:

 

1.     Ensure submission is complete
Yes. There were no issues noted from for all disciplines.

            

2.     Ensure a reviewer is assigned
Yes

 

3.     Indentify if consult review is needed
None at this time

 

4.     Notify OBRR PeRC Representative:
Yes, Nisha has been notified.

 

5.     Inspections Needed?
Yes

 

6.     BPAC eligible?
 No

 

7.     Identify follow up activities to be completed before the filing meeting
 None at this time. Also as follow up, Michael Kennedy ( SL) will let me know if any other activity is missing.
