A multidisciplinary review of a new drug from the perspective of FDA Complete Response Letters and review reports:a case study of risperidone microspheres
CHENG Si-qi
JIANG Tao
CHEN Ai-ping
TANG Zhi-quan
ZHANG Jing-chen
REN Feng
Abstract：Recently,the US FDA has publicly disclosed a substantial number of Complete Response Letters(CRLs)for various marketed products.These documents contain a wealth of information on deficiencies identified during the review process,along with corresponding recommendations for resolution,thereby offering significant reference value.Building on previous analyses of FDA CRLs,this article further narrows its focus to specialized formulations.Using the FDA-approved product Rykindo®microspheres as a case study,it analyzes the FDA's multidisciplinary review approach in issues such as in vitro drug release methods,abnormal pharmacokinetic peaks,dose-dumping risk,bridging between clinical and commercial products,and biowaivers for other strengths.Based on this analysis,the article presents insights and reflections on the multidisciplinary evaluation of specialized formulations,covering aspects like change bridging,product development and assessment,and standard establishment——which may serve as a valuable reference.
Keywords：Complete Response Letterspecialized formulationsmultidisciplinary assessmentinsights and reflectionsreference value
Publication Date：2025-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2497-2501 )