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FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the FDA

wooden nickle

Involved In Discussions
#1
We are a start-up company, we are getting deep into submitting a 505b2 for a combination product to the FDA. Can anyone advise as to what will take place during the PAI (Pre-approval Inspection)?
 
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M

MIREGMGR

#3
Re: FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the

Who will be the lead FDA modality, i.e. CDRH, CBER, CDER, other? Is there any room for reasonable disagreement as to the lists of important regulatory issues from the two (I assume) modalities?

If you're sure you understand how they'll approach the product, I think you are most of the way to your answer. If on the other hand you don't have any idea what their individual reactions will be or if they'll have compatible views, that's a tougher situation.
 

wooden nickle

Involved In Discussions
#4
Re: FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the

We need to know, who will show up at the door. We are new to the industry, our sub-contractors are established very well with the FDA. Will the inspection include them? Will the agency expect us to have a mature Quality System? etc.
 
M

MIREGMGR

#5
Re: FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the

You don't seem to have made an effort to answer the questions I asked.

Whoever wrote or is writing your 505b2 application must have some ideas, at the very least, about those answers.

If those questions are news to you, my guess would be that no one here is going to be able to answer your questions very well, except for:

Will the agency expect us to have a mature Quality System?
If by "mature" you mean complete and effective, my expectation would be yes without exception. I'm not aware of any provision of the rules that allows new companies to operate with fewer controls to achieve safety and effectiveness. Pardon my bluntness, but if you aren't "mature" enough to be able to play by all the rules, you aren't allowed to play.
 

wooden nickle

Involved In Discussions
#6
Re: FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the

Perfect! Exactly the answer I was looking for. I am in a situation where I am trying to explain the color green to a blind man.
 
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