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DIA 2013 49th Annual Meeting
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Update on Submission and GMP Expectations for Part 3 Combination Products
Track : Track 12: Pharmaceutical Quality
Program Code: 139
Date: Monday, June 24, 2013
Time: 2:30 PM to 4:00 PM  EST
Location: 153C
CHAIR :
 Michael Folkendt, MS (SCHAGY), Associate Director for Regulatory Affairs, ONDQA, OPS, CDER, FDA, United States
SPEAKER (S):
 Patricia Y. Love, MD,MBA (SPKAGY), Deputy Director, Office of Combination Products, OC, FDA, United States
Carl Fischer, PhD (SPKAGY), Chief, General Hospital Devices Branch, OC, CDRH, FDA, United States
Suzanne Kiani, MSc (SPKNON), Associate Director, CMC Regulatory, MedImmune, United States
Description
This session will provide an update on both the submission and GMP requirements for part 3 combinations products as well as the current review process. Speakers will be from the FDA Office of Combination Products, CDRH and CDER.

Session Recording
(Code: 139)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON2 Comp Access: Monday Online Access Package - June 24, 2013
Handout Online
(Code: 139)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON2 Comp Access: Monday Online Access Package - June 24, 2013
Update on Submission and GMP Expectations for Part 3 Combination Products