Note to File [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-07-24 16:57 (860 d 17:32 ago) – Posting: # 19093
Views: 1,840

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,224 posts in 4,427 threads, 1,481 registered users;
online 4 (1 registered, 3 guests [including 3 identified bots]).
Forum time: Tuesday 09:29 CET (Europe/Vienna)

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz