A snippet from the expert testimonies I'm doing—something a high court judge should understand

1. The Emergency Use Authorizations (EUAs) approved the use of the SARS-CoV-2 injections for patient administration in less than 12 months. It is my professional opinion that significant unsafe and dangerous shortcuts, in contravention of the Federal Food, Drug and Cosmetics Act and the Code of Federal Regulations, Title 21 (21 CFR, FDA), must have taken place. This can be explained as follows.

2.  The eCTD is a globally harmonized template for sponsor companies to submit the data required by any Regulatory Authority (FDA in this case) for evaluation of an application to market a new drug. The format has been agreed by country Regulatory Authorities, following regulatory collaboration and the work of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).