PDUFA VII to expand FDA’s real-time oncology reviews to supplements for all therapeutic areas
The FDA’s popular program to speed up its reviews of new oncology drugs and supplemental applications by months will be expanded into a larger program for efficacy supplements across all therapeutic areas.
The new program, to be known as Split Real-Time Application Review (STAR), first came to light in the minutes of a December meeting of the premarket subgroup working on the negotiation of the latest iteration of the Prescription Drug User Fee Act (PDUFA VII).
The program will build off the Oncology Center of Excellence’s Real-Time Oncology Review (RTOR) program, which first began in 2018 and receives submissions about 6 weeks prior to the full application and allows the FDA to sign off on approvals about 3 months early, according to data published in January.
In the December meeting, FDA sought to make STAR a pilot program that would expand the split submission and review of required sections of marketing applications to additional product types and review disciplines outside of oncology. FDA provided additional details about resources needed to establish and maintain STAR.
Another meeting of the same PDUFA VII subgroup in late January, details of which were posted on Wednesday, also noted the drafting of commitment language that would allow the STAR program to speed the review of efficacy supplements for product types in all therapeutic areas.
An industry negotiator who said he could not provide more detail, because the PDUFA VII package still needs to be signed off on by various levels of HHS, told Endpoints News that the STAR program would essentially expand RTOR to other divisions and offices in FDA’s drug and biologics centers.
Both industry and FDA previously discussed potential criteria, components, and process details for application submissions to be reviewed under STAR. Those details will become more apparent as the commitment language is finalized.
The creation of a new, wider program to allow these expedited reviews is a big win for industry, which has watched RTOR shave up to 6 months off of review times for some oncology applications, including supplements and new molecular entity approvals.