Pinnacle 21 Community 3.0.2 missing NDF-RT version

Sergiy

on January 27, 2020

P21

Hi Amanda,  Could you…

Hi Amanda, 

Could you explain why 2016-10-03 version can not work for your case?

NDF-RT dictionary have ~10 releases per year. So, we limited number of published versions for better usability. We thought that it's not an issue.

Thank you, 

Sergiy

Hi Sergiy,   A client…

Hi Sergiy,

A client specifically requested that we validate with that version. Is it possible for it to be added?

Thanks,

Amanda

Sergiy

on January 29, 2020

P21

Hi Amanda, We can provide…

Hi Amanda, 

We can provide you 2016-09-08 NDF-RT file per your request. However, I think that a problem is not related to version of the dictionary.

According to FDA Technical Conformance Guide, Pharmacologic Class for FDA submissions should be based on "the established pharmacologic class" which "is generally the MOA, PA, or CS term that is considered the most scientifically valid and clinically meaningful. Sponsors should include in TS the established pharmacologic class of all active moieties [49] of investigational products used in a study. FDA maintains a list of established pharmacologic classes of approved moieties. If the established pharmacologic class is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. For unapproved investigational active moieties where the pharmacologic class is unknown, the PCLAS record may not be available.

[49] Available at http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM346147.zip"

Based on FDA request in ~2014, original NDF-RT files were filtered for [PE], [MoA], [EPC] and [TC] terms. Later, for MED-RT dictionary (which is actually the same as older NDF-RT) a list of these classes was extended by adding [Chemical/Ingredient].

So, my assumption is that you have a term from  [Chemical/Ingredient] class.

Kind Regards,

Sergiy

APC term

Hi, Sergiy

So, the term     Vaccine [APC] N0000193912 MED-RT     which is APC and excluded from the NDF-RT 2021-11-01 txt, should not be used for PCLAS TS parameter. is that correct?

Thank you!