Advisory on the Use of Open Text Fields in APS
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Hello!
Hoping to verify how PAAB would like the manufacturer to confirm the two requisite points within this guidance (i.e., (1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive):
- Is a Med/Reg letter necessary or is a written statement within the initial cover letter/a subsequent response sufficient?
- Is a list of restricted words required in our submission for review?
As always, thank you for your time in advance.
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Happy Friday @palanski
A letter should be provided (a written statement within the initial cover letter or a separate letter) with a written statement confirming both aspects ((1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive). As inferred above, yes, this should be uploaded with the initial submission.
As the list of restricted words would not be exhaustive, it is not required as part of the submission.
