Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

摘要

Suggesting changes to the review and approval of therapeuticbiological products is a challenging task. To the best ofour knowledge, none of the academic articles identified in thisscoping review have modeled the FDA review and approvalprocess to address issues related to the robustness, reliabilityand efficiency of its operations from an internal point of view.The reform models identified in the literature are limited in severalaspects. For example, there is a general lack of applicationof scientific methodologies and modeling techniques in understandingFDA as a complex sociotechnical system. In addition,tools and methods to assess their efficacy before implementationare largely absent.