FDA Seeks Verification of ANDA Holder List for GDUFA II Fees

The FDA is asking generics makers to review the accuracy and completeness of the agency’s inventory of approved ANDA sponsors.

Fees under GDUFA II will be based on the number of ANDA approvals held by a sponsor or its subsidiary. FDA is required to compile a comprehensive list of approved ANDAs to levy the fees in fiscal 2018, when GDUFA II takes effect.

The fees for fiscal 2018 will not be announced until July, but under the proposed structure for GDUFA II, large companies, those with 20 or more approved ANDAs; medium companies, those with between 6 and 19 approved ANDAs; and small companies, those with 5 or fewer approved ANDAs, will be subject to different fees.

Comments are due within 60 days of publication in the Federal Register.