Suitability petitions, its evaluation process and US FDA’s response to the suitability petitions: Insights from the first half of GDUFA III

US FDA has committed to respond under GDUFA III within 6 months after Completeness Assessment (CA), up to a maximum of 50 suitability petitions. Underlining information in this article helps in understanding, the process of SP assessment as per GDUFA III and several reasons identified by the Agency for denial of suitability petitions. Assessment of US FDA’s 48 SP responses (posted between October 1, 2023 and April 1, 2024) reveals that 50% of petitions were approved and 50% were denied. Amongst the approved 24 SPs, 71% petitions were related to the products delivered through oral route of administration and 29% related to the injectable injections. All the SPs related to the drug products delivered through opthalmic and topical route of administrations were denied. Majority of SPs were related to the additional strength proposal and least were related to the API change proposal. In 85% of the SP responses PREA was either not triggered or not evaluated by the US FDA while in 15% of the SP responses PREA was triggered due to proposed changes and full PREA waiver was granted in 86% of cases.