Implantable Drug Delivery System (IDDS) - Manufacturers C of A Requirements

R

RAinLA

#1
We have an idds that will be used to deliver an already approved drug. We are preIDe and I would like some guidance as to what I may need to provide for a product specification regarding the drug. The drug is approved for this use. Do I need to create a specification with all attributes on the manufacturers CofA?
Thks!
 
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Stijloor

Staff member
Super Moderator
#2
We have an idds that will be used to deliver an already approved drug. We are preIDe and I would like some guidance as to what I may need to provide for a product specification regarding the drug. The drug is approved for this use. Do I need to create a specification with all attributes on the manufacturers CofA?
Thks!
Can someone help?

Thank you!

Stijloor.
 

bio_subbu

Super Moderator
#3
We have an idds that will be used to deliver an already approved drug. We are preIDe and I would like some guidance as to what I may need to provide for a product specification regarding the drug. The drug is approved for this use. Do I need to create a specification with all attributes on the manufacturers CofA?
Thks!
Can you explain a bit more? Are you submitting the IDDS for approval as a separate medical device or will the final product be marketed as a combination device/drug? What is meant by "manufactures C of A"?
 
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