5 Medical Writing Best Practices For Gene Therapy BLA/MAA Submissions

Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template. For example, some required document topics may apply in a different way, and some Common Technical Document (CTD) sections may not be applicable in gene therapy submissions. However, the challenges associated with contextualizing data that fall outside of conventional document template categories can be overcome through the application of some general best practices.