FDA to test STAR pilot for original applications

The US Food and Drug Administration (FDA) on Monday announced that it will accept a limited number of original marketing applications from its drug and biologics centers to participate in the Split Real Time Application Review (STAR) pilot program.

The pilot was previously only available to certain efficacy supplements for existing drugs and biologics that address an unmet medical need and was mandated by the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII). (RELATED: FDA offers details on PDUFA VII STAR review pilot, Regulatory Focus 4 October 2022)

Beginning on 2 December, both CDER and CBER will accept up to two original applications into the program. Each center will accept the first two applications that qualify based on four criteria laid out by the agency. Priority will be given to those applications with the earliest planned submission date. The next qualified applicant in the queue will be accepted if the first applicants are unable to submit information by that date.

To be eligible, sponsors must provide evidence from “adequate ad well-controlled” investigations that the drug or biologic demonstrates “substantial improvement” on a clinically relevant endpoint over available therapies; the therapy is intended to treat a serious condition with an unmet need; and the submission will not require a longer review time, such as a being likely to need a new risk evaluation and mitigation strategy (REMS); and there is no chemistry, manufacturing, or control (CMC) information that would require a foreign manufacturing site inspection.

The program differs from other pilots such as the Real-Time Oncology Review (RTOR) pilot, as the STAR pilot is a PDUFA program open to development programs from any therapeutic area, while RTOR is not a PDUFA program and is only available for oncology drugs, an FDA official explained at RAPS Convergence in September 2024. It also differs from a rolling review, which is only available to drugs with a fast track or breakthrough therapy designation. (RELATED: Convergence: FDA officials offer updates on START, STAR pilots, Regulatory Focus 24 September 2024).

FDA said it will respond to applications within 3-5 business days.

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FDA to test STAR pilot for original applications

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