FDA Clarifies the Relief GDUFA II Gives to Small Businesses

Small businesses sponsoring approved generics can expect a 90 percent discount on annual user fees, offering them some relief when GDUFA II takes effect in fiscal 2018.

The next iteration of the user fee agreement, which awaits Congressional approval, will introduce a three-tier annual fee that will only be assessed after an approved ANDA is identified, which means firms referenced in a pending ANDA will no longer face annual dues.

The annual fee will be based on a company’s approved ANDAs, according to Gisa Perez, the generic branch chief in the FDA’s division of user fee management and budget formulation.