Dear Narayan,
Thanks for your information, it is a great help to me.
It looks like that the labeling requirements is not define in regulation.
The information you added is practical rule in the industry, isn't it?
In case of "Name of the company/address", does this information means the supplier of investigational new drug or manufacturer of this product?
Our company is a small biotech company, so the manufacturer is other company (OEM manufacturer).
So it is not proper to show the manufacturer name on it.
Is it possible to written it as "supplier" or "provider" for "Name of the company" section on it?
Thanks a lot.
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InPyo Hong MS
Seoul
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Original Message:
Sent: 22-Sep-2020 12:34
From: Narayan Rao
Subject: Labeling requirements for investigator initiated trials in US
Labeling of the Drug for investigational use:
(21CFR312.6)
- The immediate package of an investigational new drug intended for use shall bear a label with the statement "Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use" (This one sentence is mandatory)
- The label or labeling of an investigational new drug may not bear any false or misleading statements or claim that is safe or effective
If the following information is provided in the label, then you are good to go:
Protocol #
IND name/#: xxxxx
Product Name/strength, dosage form: xxx....mg/vial, or mg/tablets......etc
Dosage Form/Route of administration:
Use according to the Protocol
Storage Condition:
Caution: New Drug--Limited by Federal (or United States) Law to Investigational Use
Name of the company/address
In addition, if your product requires special handling like "Do Not Shake" or Do not expose to light etc include it as well.
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GRSAOnline
Original Message:
Sent: 22-Sep-2020 07:53
From: InPyo Hong
Subject: Labeling requirements for investigator initiated trials in US
We are preparing a investigational new drug for investigator initiated trials in US, but it is difficult to labeling requirements for our investigational new drug.
What I can find in FDA regulation site is only one sentence about it.
Could you help me for labeling requirement for investigational new drug for IIT in US?
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Inpyo Hong Mr.
Seoul
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