Note to File [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-07-24 16:57 (790 d 23:02 ago) – Posting: # 19093
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Hi Kakarla,

IMHO, no big deal.
stands for an unregistered trademark, as opposed to an registered trademark ®. Will not affect the safety of the subjects in the study. Hence, no substantial amendment (EC and regulatory approval) is required. Maybe just a “Note to File” is enough. If you want to be on the safe side, go for an administrative amendment.

Dif-tor heh smusma 🖖
Helmut Schütz
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