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.

Hey @SKW

As Patrick Massad is now the Commissioner, you should reach out to Yin Man, Senior Reviewer of Preclearance, to request opinion meetings. We have updated the website accordingly. Additionally, you are not restricted to the number of attendees from the Pharma company.

Thank you for the questions.

Hey @palanski and team

You are correct. Relative claims may appear as the main message (headline), when they include the absolute values. These should be presented as an integral part of the claim and should NOT be a different colour, style, size etc. All other aspects (quantification and qualification) you would normally include in the claim, still remain applicable.