The US Food and Drug Administration is expanding the Split Real Time Application Review (STAR) approach beyond the confines of the current pilot program for efficacy supplements, which appears to have drawn little industry interest to date.
Looking For STARs: US FDA Expands Split Real Time Review Amid Low Supplement Interest
The STAR pilot established in PDUFA VII for efficacy supplements, which was modeled after the popular Real Time Oncology Review program, has not garnered much interest. The agency now is establishing a separate but similar pilot for a small number of original NDAs and BLAs.
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