Recombinant allergens: what needs to come next?

4/5/02


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Table of Contents

Recombinant allergens: what needs to come next?

Where we are with natural allergens

Where we are with natural allergens

Where we are with natural allergens

Where we are with natural allergens - summary

How can we improve the use of natural allergens?

How can we improve the use of natural allergens?

Where we are with recombinant allergens

Where we can be with recombinant allergens

Where we can be with recombinant allergens

Where are we in the process?

How does the FDA decide?

Guidance documents that apply to allergenic products

Guidance documents that apply specifically to recombinant products

How to get there from here

How to get there from here

How to get there from here

IND process

FDA’s objectives in reviewing an IND:

IND - Phase 1

Reasons for “hold” on Phase 1 study

IND - Phase 2

IND - Phase 3

Reasons for “hold” on Phase 2/3 study

IND process

How to get there from here

Study power

How to get there from here

How to get there from here

How to get there from here

But it has been done before...

Resources

Author: CBER