Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

If FDA does not agree with they Type of meeting a Sponsor has requested, do they deny the meeting & require the Sponsor to resubmit the meeting request as a different Type - or do they classify the Type of meeting.   

For example:  If a Sponsor submits a Type B EOP meeting & FDA sees merit in the meeting request but believes it is a Type C meeting rather than a Type B EOP, is the Agency more likely to: 

1. respond in 21 days telling the Sponsor that it needs to resubmit the meeting request as a Type C (and thus needing to wait another 21 days for a Type C meeting request reply) 

or

2. respond telling the sponsor that the request is a Type C and provide a meeting date within the 75 days window.  

Any experiences are welcome.

Many thanks in advance.

My experience is that they will grant the meeting, but in the response granting the meeting state the type of meeting granted and why.  FDA rarely flat out denies a meeting if the questions are substantive  - it is mostly like to happen for a preIND if all of the questions can be answered by reading a guidance document or two.  They will provide the date ~75 days later as you have suggested.  Note that they also could decide that they will only grant a written response if they do not consider the issues substantive enough to require discussion.  It generally is pretty obvious when an EOP meeting is warranted, but it depends on the issues to be discussed.  For example, if one were to request an EOP2 meeting, but not have Phase 2 data and a Phase 3 program to discuss, it is not likely that a Type B meeting would be granted.

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 14-Oct-2018 18:45
From: Anonymous Member
Subject: FDA Meeting Denied? Reclassify meeting type?

This message was posted by a user wishing to remain anonymous

If FDA does not agree with they Type of meeting a Sponsor has requested, do they deny the meeting & require the Sponsor to resubmit the meeting request as a different Type - or do they classify the Type of meeting.

For example:  If a Sponsor submits a Type B EOP meeting & FDA sees merit in the meeting request but believes it is a Type C meeting rather than a Type B EOP, is the Agency more likely to:

1. respond in 21 days telling the Sponsor that it needs to resubmit the meeting request as a Type C (and thus needing to wait another 21 days for a Type C meeting request reply)

or

2. respond telling the sponsor that the request is a Type C and provide a meeting date within the 75 days window.

Any experiences are welcome.

Many thanks in advance.

#2​

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Lauren Neighbours PhD, RAC
Head of Regulatory Affairs
Cary NC
United States
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Original Message:
Sent: 14-Oct-2018 18:45
From: Anonymous Member
Subject: FDA Meeting Denied? Reclassify meeting type?

This message was posted by a user wishing to remain anonymous

If FDA does not agree with they Type of meeting a Sponsor has requested, do they deny the meeting & require the Sponsor to resubmit the meeting request as a different Type - or do they classify the Type of meeting.

For example:  If a Sponsor submits a Type B EOP meeting & FDA sees merit in the meeting request but believes it is a Type C meeting rather than a Type B EOP, is the Agency more likely to:

1. respond in 21 days telling the Sponsor that it needs to resubmit the meeting request as a Type C (and thus needing to wait another 21 days for a Type C meeting request reply)

or

2. respond telling the sponsor that the request is a Type C and provide a meeting date within the 75 days window.

Any experiences are welcome.

Many thanks in advance.

This message was posted by a user wishing to remain anonymous

Response 2 i.e. FDA would reclassify it as Type C.
Original Message:
Sent: 14-Oct-2018 18:45
From: Anonymous Member
Subject: FDA Meeting Denied? Reclassify meeting type?

This message was posted by a user wishing to remain anonymous

If FDA does not agree with they Type of meeting a Sponsor has requested, do they deny the meeting & require the Sponsor to resubmit the meeting request as a different Type - or do they classify the Type of meeting.

For example:  If a Sponsor submits a Type B EOP meeting & FDA sees merit in the meeting request but believes it is a Type C meeting rather than a Type B EOP, is the Agency more likely to:

1. respond in 21 days telling the Sponsor that it needs to resubmit the meeting request as a Type C (and thus needing to wait another 21 days for a Type C meeting request reply)

or

2. respond telling the sponsor that the request is a Type C and provide a meeting date within the 75 days window.

Any experiences are welcome.

Many thanks in advance.