Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines

J

jmlbell

#1
#1
I am trying to find guidelines regarding biologic injectable device clinical trial packaging/artwork/labeling for the US.

I can see FDA guidelines for commercialised product but not for clinical trials.

Can anyone help me?

All the best,

jmlbell
 
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Ronen E

Ronen E

Problem Solver
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#2
#2
:confused:

You are writing about an "injectable device" but have posted in the pharmaceuticals regulation forum. Is it a medical device or something else? If a device, are you referring to the injector or to its contents?

Welcome to Elsmar's discussions :bigwave:
 
J

jmlbell

#3
#3
Thanks Ronen,

In Europe a biologics injectable device is regulated as a pharmaceutical medicine rather than a medical device so that is why I posted here. I am talking about a biologic medical device-pharmaceutical medicine combination product.

I have come across the following from the FDA:

How is a product classified if it meets the definitions for both drug and device, and might also meet the definition for biological product?(I am unable to post the web link at this time)

I am specifically interested in the approach to get the biologic device through clinical trials in the US. I am able to find information on commercialised product but nothing substantial on investigational medicinal product.

Can anyone help?
 
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Ronen E

Ronen E

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#4
#4
Thanks for trying to clarify. Perhaps it's just me, but I'm still not sure what exact product we are discussing.

Are we discussing a combination device, consisting of some injector that is offered for use pre-filled with (or pre-loaded with a cartridge of) a biological drug?
 
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