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rajasekharkakarla ☆ India, 2018-07-24 11:05 (1956 d 09:49 ago) Posting: # 19087 Views: 2,374 |
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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 |
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Helmut ★★★   Vienna, Austria, 2018-07-24 18:57 (1956 d 01:57 ago) @ rajasekharkakarla Posting: # 19093 Views: 2,213 |
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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 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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rajasekharkakarla ☆ India, 2018-07-30 15:37 (1950 d 05:16 ago) @ Helmut Posting: # 19115 Views: 2,319 |
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Dear Sir, Thank you for your clarification. Thanks and Regards, Kakarla Rajasekhar |
Ing. Helmut Schütz