Regulatory submissions future issues

Conclusions. Briefly summarize the overall development process. The summary may include a time line that displays the initiation, key intermediate steps, and completion of work in such critical areas as validation of methods, safety studies, clinical studies, scale-up, process validation, and times of regulatory submissions. The summary should also identify key issues to be resolved (including future work to be done, if any). Finally, the summary should provide a conclusive statement that links each section of the development report and addresses the equivalency of the clinical biobatches to the production batches. Include information from in vivo and invitro studies as appropriate. 

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