1.7.1 Fast Track Designation

1.7.1 Fast Track Designation

1.7.1 Fast Track Designation

This application is for sponsors looking for Fast Track Designation on their product. This requires detailing the seriousness of the condition, the basis for the unmet need, and the development plan.


Read the original FDA guidance on Fast Track Designation.

This application is for sponsors looking for Fast Track Designation on their product. This requires detailing the seriousness of the condition, the basis for the unmet need, and the development plan.


Read the original FDA guidance on Fast Track Designation.

This application is for sponsors looking for Fast Track Designation on their product. This requires detailing the seriousness of the condition, the basis for the unmet need, and the development plan.


Read the original FDA guidance on Fast Track Designation.

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