Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,

In my experience, clarifications can be obtained by communicating with the RPM. Additional advice on a new topic is a bit harder to deal with. A formal written request for advice about a single or few questions may be required, but don't expect a quick answer. Depending on the complexity of the question(s) it could be 60 days or more before getting a response. There are many factors that will determine FDA's priority in responding - novelty of the compound, medical need, fast track, etc.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 02-Jun-2022 12:29
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,

This message was posted by a user wishing to remain anonymous

They usually offer clarification teleconference after you receive preliminary written responses.
Original Message:
Sent: 02-Jun-2022 12:29
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,

That is not my experience, but it may be Division dependent.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 03-Jun-2022 10:44
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

They usually offer clarification teleconference after you receive preliminary written responses.
Original Message:
Sent: 02-Jun-2022 12:29
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,

You may submit a request for clarification on FDA's written responses meeting summary through the RPM. Please note that questions for clarification should be within the scope of the previously discussed questions presented in the briefing package. Also, any feedback or advice provided after the meeting will be considered informal  advice and wont be included in the original meeting summary. Alternatively, you may seek feedback on any new questions by submitting either a new meeting request or filing an amendment to the IND (if under IND) requesting FDA advice on new topics with reference the supporting documentation in your IND submission. If you file an IND amendment it is a good idea to clearly state in your cover letter that you are seeking advice and follow-up with the RPM on the file by sending a quick email. As others have mentioned earlier in this post, these additional reviews do not follow P/MDUFA timelines and the response may take 60 days+ depending on the responsible Office resources and competing priorities. I hope this helps.

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
------------------------------

Original Message:
Sent: 02-Jun-2022 12:29
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,

One other important consideration is to immediately contact the RPM, by telephone or email, upon identifying any response that needs clarification so as to take advantage of the momentum from receiving the WRO.  Don't wait weeks or months to make contact.  My recent WRO letters state to contact the RPM with any issues so when time is of the essence move quickly.

Best,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 07-Jun-2022 10:30
From: Juliane Carvalho
Subject: Type B meeting

You may submit a request for clarification on FDA's written responses meeting summary through the RPM. Please note that questions for clarification should be within the scope of the previously discussed questions presented in the briefing package. Also, any feedback or advice provided after the meeting will be considered informal  advice and wont be included in the original meeting summary. Alternatively, you may seek feedback on any new questions by submitting either a new meeting request or filing an amendment to the IND (if under IND) requesting FDA advice on new topics with reference the supporting documentation in your IND submission. If you file an IND amendment it is a good idea to clearly state in your cover letter that you are seeking advice and follow-up with the RPM on the file by sending a quick email. As others have mentioned earlier in this post, these additional reviews do not follow P/MDUFA timelines and the response may take 60 days+ depending on the responsible Office resources and competing priorities. I hope this helps.

------------------------------
Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**

Original Message:
Sent: 02-Jun-2022 12:29
From: Anonymous Member
Subject: Type B meeting

This message was posted by a user wishing to remain anonymous

Hi,

I have a question on Type B Meeting, where you received FDA feedback as a written response only. What are the options/approach, you would recommend if you have a clarification questions or need additional inputs after written response received.

Thank You,