Mid-Cycle Meeting Minutes - Atryn
|Date:||October 8, 2008|
|Re:||Mid-Cycle Meeting Minutes|
Date: October 8, 2008
Location: WOC, 300N
Time: 10:00 am-11:30am
Attendees: Iftekhar Mahmood, Joseph Manik, Faith Barash, Chiang Syin, Evi Struble, Paul Hshieh, Nisha Jain, Roman Drews, Robert Wise, Jeffrey Anderson, Pratibha Rana
- There were no major issues noted at this time for all disciplines.
- Regarding the labeling the following information will be requested:
- In order to support your claim “clearance and volume of distribution are significantly increased in pregnant patients as compared to non-pregnant patients". Please provide PK data to the FDA for both pregnant and non-pregnant women for comparison purposes. The data should consists of age, weight, dose, plasma concentrations vs time data, and estimated PK parameters in these subjects (pregnant and non-pregnant women).
- The established name will be recommended to change from antithrombin alfa to antithrombin III (Recombinant) to comply with the nomenclature used by CBER/OBRR.
- We also filled the OBRR Mid-Cycle Review Checklist form and following items were checked in the form.
- Proprietary Name review has been submitted and found acceptable, 3/7/08
- BPAC is planned for January 9, 2009.
- Lot Release is not required
- Post Marketing requirements (PMR) is planned to be requested.
- The review committee was notified of the new midcycle memo due date of October 15, 2008.