OK from the FDA site Booz Allen assessed the r

OK from the FDA site

Booz Allen assessed the readiness of five submission format and study data standards and five controlled terminology standards,
which apply to submissions across the regulatory review process, and to both clinical and non-clinical data. FDA is accepting a
version of all of the investigated standards and has already mandated submission of most standards for many application types. As
standards are continually evolving, FDA must continuously review newly released standards before providing support. Interviews
with FDA staff revealed that FDA provides proactive subject matter expert (SME) input on changes to standards during the Standards
Developing Organization (SDO) development process. This collaboration with the SDOs reduces the review time needed for eventual
FDA support of new standards. However, without a mock dataset submission from the SDOs that incorporates the updates to be
included in the new version of the standard, FDA is not able to fully determine the impact, through testing, that the proposed
changes have on their ability to analyze future data with current analysis tools.