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Timelines for PIP and PSP process. PSP review slide provided from the FDA.
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Due to the PSP timelines, which in contrast to the PIP timelines do not include any formal clock-stop (see Figure 3), and due to short time to complete the PSP process, FDA provided the applicant with rather short time:30 days:to respond to their comments and requested changes. As seen in Figure 3, PeRC review is an integral part of the PSP process, and will typically discuss such questions as, What is the public health benefit? Are the study designs feasible and sufficient to support dosing, safety, and efficacy? Have all populations and conditions been addressed? and, Are there other products already approved for the condition? In contrast to the PDCO, which has an approving role, PeRC is an advisory committee, and PDCO has the final authority to decide on the PSP.