Snapshot

The Generating Antibiotic Incentives Now (GAIN) pathway has been developed by the of United States.

This pathway can be used where Qualified Infectious Disease Products (QIDPs). .

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Sponsors may request QIDP designation, and FDA will review the request and respond within 60 days of submission. To determine whether a product can be designated, FDA considers whether the product is an antibacterial or antifungal drug and whether it is intended to diagnose, prevent, or treat a serious or life-threatening infection.