j Jassi
on

 

Is this rule applicable for Non-PMDA studies? If yes, Can you provide a link to where guidelines are posted?

 

Thanks,

Regards,

Jassi

Forums: Define.xml

s Sergiy
on March 16, 2016

Hi Jassi, 

DD0086 rule should work for FDA submission only. Some FDA tools require this limitation on length of values in define file attributes.

The rule is not applicable for PMDA submissions. It was included in PMDA configuration by mistake in v2.1. New version 2.1.1 will be released later this week and does not have this bug.

Kind Regards,

Sergiy

 

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