Development Meeting with the FDA - Approval Pathway for a Combination Product

[fialor]

Hi All,
My company is at present looking to have a meeting with the FDA regarding an approval pathway for a combination product.

I would appreciate any pointers that you may have on manaing this meeting, especially if you have any experience of this.

I am aware of the FDA guidance document "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products". Revision 2 Draft. And also the Q-Sub guidance document for device manufacturers. But any others you have would be veryhelpful.

Thank you
Fialor

 

[Stijloor]

A Quick Bump!

Can someone help? Thank you very much!

 

[shimonv]

Hi fialor,
I have only been once to a formal meeting with FDA. Just a few pointers:
1. Your questions to the agency should be crafted very carefully.
2. Your team should include all the relevent subject matter expert.
3. Despite your efforts for clarity in the meeting package, not all will understand. Therefore, aim low and walk them through the precess.
4. Take notes during the meeting to make sure capture everything.
5. Try to establish a relationship with the lead reviewer so you can contact him later on for informal questions / clarifications.
6. Stick to the agenda so you can cover all topics and reach the meeting goal.
7. In the end of the meeting, make sure you summarise the key points and get their agreement, and advise on the next steps.

Best,
Shimon

 

[chris1price]

Hi, Shimonv makes some very good points. I would also make sure everyone is familiar with the recently released Final Rule on cGMPs and Combination Products so there are no surprises.

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm

Chris