Hello,
If the generic name is used by multiple products than this will not be acceptable because it has to be clear which product you are testing. The name of the product should be consistent in the study documents (you cannot have one name on the protocol and another name of the product description).
Have a great weekend.
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/United Kingdom
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Original Message:
Sent: 25-Apr-2024 02:11
From: Anonymous Member
Subject: Requesting kind advice : A fictional pilot scale interventional study with health supplements.
This message was posted by a user wishing to remain anonymous
Requesting kind advice : A fictional pilot scale interventional study with health supplements.
Is it mandated that the name of the investigational product that appear in product description document and the study protocol remain the same?
In situations where the study protocol has not mentioned the exact name of the product (manufactured) but mentions only the generic term of the product (commonly known to people).Will this cause rejection of application by the regulatory authority?