rajasekharkakarla
☆    

India,
2018-07-24 11:05
(1897 d 07:40 ago)

Posting: # 19087
Views: 2,347
 

 Reference trademark issue [Regulatives / Guidelines]

Post reply
Dear All,

I prepared protocol for Mesalamine delayed-release tablets 1.2 gm for USFDA submission, i written reference name as Lialda™ (mesalamine) delayed release tablets 1.2 gm with trademark TM and the protocol was approved by EC. But as per COA it is mentioned as Lialda®, there is change in trademark. kindly suggest whether i need to go with ammendment/not.

Regards'
Kakarla
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-07-24 18:57
(1896 d 23:48 ago)

@ rajasekharkakarla
Posting: # 19093
Views: 2,190
 

 Note to File

Post reply
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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

India,
2018-07-30 15:37
(1891 d 03:07 ago)

@ Helmut
Posting: # 19115
Views: 2,295
 

 Note to File

Post reply
Dear Sir,

Thank you for your clarification.

Thanks and Regards,
Kakarla Rajasekhar
 
UA Flag
Activity
 Admin contact
22,770 posts in 4,777 threads, 1,627 registered users;
15 visitors (1 registered, 14 guests [including 5 identified bots]).
Forum time: 18:45 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5