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FDA panel: suitability petitions are fee-exempt, but cited ANDAs will incur GDUFA fees
Summary
Rosie Pagaduan said suitability petitions themselves are exempt from GDUFA user fees, but if an ANDA is later submitted it will be subject to GDUFA fees; she also said multiple strengths approved under separate petitions can be combined in one ANDA if both petitions reference the same RLD.
An online attendee asked whether a product with multiple strengths approved under separate suitability petitions can be approved in a single ANDA and whether suitability petitions are subject to GDUFA user fees.
Rosie Pagaduan, supervisory general health scientist at the Office of Regulatory Operations in the Office of Generic Drugs, said "the short answer is yes" — applicants can cite multiple approved petitions in one ANDA provided both petitions reference the same reference listed drug. She added that "suitability petitions themselves are exempt from user fees," but cautioned that "once an ANDA is submitted, that ANDA is subject to GDUFA fees."
Practical takeaway: applicants relying on petitions to support multiple strengths should ensure each petition cites the same RLD and be prepared to pay ANDA user fees at the time of submission.
