I don't predict that the statement will be an issue that would cause problems, but it does stimulate questions. Like: "What does that mean?" "Will this 'measure' impact stability?" "Were stability studies done under these conditions of use?" It may be obvious to the reviewer based on the type of product you are developing why you would need child safety and tamper evidence for an IND study, but it is obvious from your description.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 10-Sep-2019 08:53
From: Anonymous Member
Subject: IND secondary packaging
This message was posted by a user wishing to remain anonymous
Hello Forum,
For a tablet/capsule formulation, the secondary packaging for our product is not intended to provide additional protection for the drug product. Since the emphasis is on primary packaging, can the initial IND submission only include a short sentence for secondary packaging as suggested below:
"appropriate measures are taken to ensure child safety and temper evidence"
No further secondary packaging info will be included in the IND. Does this sound like something that may be an issue during FDA review of IND?
Thank you.
Anonymous