Update from CBER FDA

1502

Friday, March 3, 2017: 12:45 PM-2:00 PM

Georgia World Congress Center, Building B, Level 2, Room B206

1.25 CME/CE

Workshop

Moderator:

Jay E. Slater , MD

Learning Objectives:

Identify FDA standards in approving new allergen immunotherapy products, including use of challenge procedures and statistical standards
Discuss considerations for conduct of trials for novel food allergy immunotherapy products
Discuss considerations for conduct of trials for products that prevent the development of allergic disease

This Session Will Use Audience Response Technology.

12:45 PM

Year-in-Review at CBER FDA
Ronald L. Rabin, MD FAAAAI

1:00 PM

Lessons Learned from Recent Allergenic Product Approvals
Joohee Lee, MD

1:15 PM

Approval of Food Allergy Immunotherapy Products
Kathleen S. Hise, MD

1:30 PM

Approval of Products for the Prevention of Allergy
Suyoung Tina Chang, MD

1:45 PM

Question & Answer

See more of: Session