Engine Compatibility

k Kent

on May 5, 2020

On https://www.pinnacle21.com/projects/validator/engine-compatibility you have the following guidance on Engine compatibility

FDA - Validation engine currently deployed at FDA. Use to prepare for imminent submission.
PMDA - Validation engine for PMDA rules v2.0. Valid for use with applications from April 1st, 2020.
PMDA Legacy - Validation engine for PMDA rules v1.0. Valid for use with applications from October 1st, 2016 through March 31, 2021.

I suspect there may be a typo as it would appear for PMDA submission from April 1 2020 to March 31, 2021 that two difference ENGINEs should be selected. Can you confirm what is correct in this situation?

thanks

Kent

Forums: General Discussion

Sergiy

on May 8, 2020

P21

It's correct. Either version of PMDA rules ...

Hi Kent,

It's correct. For PMDA submissions filled during 2020-04-01 through 2021-03-31 you can select either PMDA (1810.3 engine) or PMDA Legacy (1511.6) rules. Be sure that you utilize the same version of rules (P21 engine) for all studies within your submission.

Please see PMDA Guidance documentation for details. You can start with links provided at https://www.pinnacle21.com/useful-links

Kind Regards,

Sergiy