Regulatory Open Forum

Has anyone observed any uptick in FDA denials of meeting requests lately? My client was recently denied what they thought would be an appropriate pre-IND meeting and they're trying to understand if there's more behind the agency's vague rationale (e.g., resource constraints, prioritization, other?).

Thanks for any & all insight!

Can you be more specific with regards to the denial - has the agency denied an actual meeting and requested to convert to a WRO (written response only)?  Or have they outright denied a meeting, period?   If the former (denied with conversion to a WRO), I have seen that trend begin 5+ years ago for CBER...

Has anyone observed any uptick in FDA denials of meeting requests lately? My client was recently denied what they thought would be an appropriate pre-IND meeting and they're trying to understand if there's more behind the agency's vague rationale (e.g., resource constraints, prioritization, other?).

Thanks for any & all insight!

Meeting was totally denied. FDA said the questions would be addressed in review of the IND.

Can you be more specific with regards to the denial - has the agency denied an actual meeting and requested to convert to a WRO (written response only)?  Or have they outright denied a meeting, period?   If the former (denied with conversion to a WRO), I have seen that trend begin 5+ years ago for CBER...

Has anyone observed any uptick in FDA denials of meeting requests lately? My client was recently denied what they thought would be an appropriate pre-IND meeting and they're trying to understand if there's more behind the agency's vague rationale (e.g., resource constraints, prioritization, other?).

Thanks for any & all insight!

I've seen FDA extend the meeting date beyond the timelines in the PDUFA meetings guidance based on resource constraints.  It is rare for them to deny a pIND meeting outright if the appropriate process was followed for submitting the meeting request.  I would need more details to provide any additional assessment.  

Meeting was totally denied. FDA said the questions would be addressed in review of the IND.

Can you be more specific with regards to the denial - has the agency denied an actual meeting and requested to convert to a WRO (written response only)?  Or have they outright denied a meeting, period?   If the former (denied with conversion to a WRO), I have seen that trend begin 5+ years ago for CBER...

Has anyone observed any uptick in FDA denials of meeting requests lately? My client was recently denied what they thought would be an appropriate pre-IND meeting and they're trying to understand if there's more behind the agency's vague rationale (e.g., resource constraints, prioritization, other?).

Thanks for any & all insight!

Thanks, Michelle. As I mentioned above, the meeting was totally denied. FDA said the sponsor's questions would be addressed in its review of the IND.

I've seen FDA extend the meeting date beyond the timelines in the PDUFA meetings guidance based on resource constraints.  It is rare for them to deny a pIND meeting outright if the appropriate process was followed for submitting the meeting request.  I would need more details to provide any additional assessment.  

Meeting was totally denied. FDA said the questions would be addressed in review of the IND.

Can you be more specific with regards to the denial - has the agency denied an actual meeting and requested to convert to a WRO (written response only)?  Or have they outright denied a meeting, period?   If the former (denied with conversion to a WRO), I have seen that trend begin 5+ years ago for CBER...

Has anyone observed any uptick in FDA denials of meeting requests lately? My client was recently denied what they thought would be an appropriate pre-IND meeting and they're trying to understand if there's more behind the agency's vague rationale (e.g., resource constraints, prioritization, other?).

Thanks for any & all insight!