Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

For BTD products, FDA Guidance states that : "Subsequent meetings for breakthrough therapy-designated products will be considered either Type B or possibly Type A meetings if the meeting request meets the criteria for a Type A meeting". 

I would assume that this applies to RMAT designation as well.

We are currently discussing EOP2 timelines in a context of a BTD or RMAT drug. 
As this is a dedicated category - Type B (EOP) meetings, I would think that despite having a BTD, we still have to rely on the EOP2 timelines (request 70d/BB 50d) and this would not switch to a classic Type B meeting (60d/30d). 

Do you agree? 

Thank you!

Best Regards. 

Good afternoon, 

You can ask for clarification in your meeting request. 

Best of luck,


------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
------------------------------

Original Message:
Sent: 12-Sep-2022 15:46
From: Anonymous Member
Subject: EOP2 timelines and BTD/RMAT Designation

This message was posted by a user wishing to remain anonymous

Hi all,

For BTD products, FDA Guidance states that : "Subsequent meetings for breakthrough therapy-designated products will be considered either Type B or possibly Type A meetings if the meeting request meets the criteria for a Type A meeting".

I would assume that this applies to RMAT designation as well.

We are currently discussing EOP2 timelines in a context of a BTD or RMAT drug.
As this is a dedicated category - Type B (EOP) meetings, I would think that despite having a BTD, we still have to rely on the EOP2 timelines (request 70d/BB 50d) and this would not switch to a classic Type B meeting (60d/30d).

Do you agree?

Thank you!

Best Regards.