The field of gene therapy is growing exponentially, with The first gene therapy study was carried out in 1989 and since then, around 2600 clinical trials have been conducted. To help companies overcome issues surrounding the development and commercialization of gene therapies, the FDA directs considerable effort toward the development of regulatory frameworks and policies that provide necessary guidance to the industry. On January 28, 2020, the FDA issued Chemistry, Manufacturing, and Control (CMC) information for human gene therapy Investigational New Drug applications (INDs). The FDA's guidance document provides recommendations to sponsors of human gene therapy INDs on how to include sufficient CMC information to delineate the safety, quality, strength, and purity of the investigational product in an original IND application.
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