Regulatory Open Forum

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

During the COVID era, CBER has been delaying pre-IND meetings by at least 60 days. We had 2 pre-IND meetings in this era (both last year), both of which were delayed by 60 days - which means CBER delayed the receipt date of the meeting request by 2 months. Another change was (it seems for most if not all sponsors, per our FDA RPM) that all meetings were changed to Written Request Only (WRO) regardless of what was requested.

For our first meeting we had requested a telecon, but it was changed to WRO. The 2nd meeting we just requested as a WRO to avoid any more delays in the interactions/back-and-forth that happen otherwise. 

After the 2 month delay, the standard timeline of 60 days was given. Note that the original meeting delayed letter from FDA does not guarantee a meeting confirmation even after the first 60 day delay - which means they leave room open for themselves to further delay if they need to.

With PHE ending soon, not sure how this will impact the meeting timelines and formats.

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

Thanks so much for the helpful input. Could you share which division at CBER this was for? 

My meeting request would be for a vaccine (not COVID).

Thanks

During the COVID era, CBER has been delaying pre-IND meetings by at least 60 days. We had 2 pre-IND meetings in this era (both last year), both of which were delayed by 60 days - which means CBER delayed the receipt date of the meeting request by 2 months. Another change was (it seems for most if not all sponsors, per our FDA RPM) that all meetings were changed to Written Request Only (WRO) regardless of what was requested.

For our first meeting we had requested a telecon, but it was changed to WRO. The 2nd meeting we just requested as a WRO to avoid any more delays in the interactions/back-and-forth that happen otherwise. 

After the 2 month delay, the standard timeline of 60 days was given. Note that the original meeting delayed letter from FDA does not guarantee a meeting confirmation even after the first 60 day delay - which means they leave room open for themselves to further delay if they need to.

With PHE ending soon, not sure how this will impact the meeting timelines and formats.

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

This was with OVRR; our pre-INDs were for vaccines (not for COVID also).

Thanks so much for the helpful input. Could you share which division at CBER this was for? 

My meeting request would be for a vaccine (not COVID).

Thanks

During the COVID era, CBER has been delaying pre-IND meetings by at least 60 days. We had 2 pre-IND meetings in this era (both last year), both of which were delayed by 60 days - which means CBER delayed the receipt date of the meeting request by 2 months. Another change was (it seems for most if not all sponsors, per our FDA RPM) that all meetings were changed to Written Request Only (WRO) regardless of what was requested.

For our first meeting we had requested a telecon, but it was changed to WRO. The 2nd meeting we just requested as a WRO to avoid any more delays in the interactions/back-and-forth that happen otherwise. 

After the 2 month delay, the standard timeline of 60 days was given. Note that the original meeting delayed letter from FDA does not guarantee a meeting confirmation even after the first 60 day delay - which means they leave room open for themselves to further delay if they need to.

With PHE ending soon, not sure how this will impact the meeting timelines and formats.

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

During the COVID era, CBER has been delaying pre-IND meetings by at least 60 days. We had 2 pre-IND meetings in this era (both last year), both of which were delayed by 60 days - which means CBER delayed the receipt date of the meeting request by 2 months. Another change was (it seems for most if not all sponsors, per our FDA RPM) that all meetings were changed to Written Request Only (WRO) regardless of what was requested.

For our first meeting we had requested a telecon, but it was changed to WRO. The 2nd meeting we just requested as a WRO to avoid any more delays in the interactions/back-and-forth that happen otherwise. 

After the 2 month delay, the standard timeline of 60 days was given. Note that the original meeting delayed letter from FDA does not guarantee a meeting confirmation even after the first 60 day delay - which means they leave room open for themselves to further delay if they need to.

With PHE ending soon, not sure how this will impact the meeting timelines and formats.

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

hey,

I have had recent experience with pre-IND meeting requests with CBER (OTAT/OTP specifically this year and last year) and in both instances CBER complied with the published/PDUFA-mandated timelines. Specifically, we received confirmation of WRO within 21 days of the meeting requests being submitted, and the WRO arrived within the 60 day timeline.

best,

Catherine

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

Catherine, Thanks so much for the helpful input. 

My meeting request would be for a vaccine (not COVID).  If you or others have input for this Division, appreciate that also?

Thanks!

hey,

I have had recent experience with pre-IND meeting requests with CBER (OTAT/OTP specifically this year and last year) and in both instances CBER complied with the published/PDUFA-mandated timelines. Specifically, we received confirmation of WRO within 21 days of the meeting requests being submitted, and the WRO arrived within the 60 day timeline.

best,

Catherine

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!

The Anon's response above is more accurate with regards to pre-IND meeting requests and responses! CBER is general term but it has significant unique divisions to manage! So, although yours is not a Covid vaccine, it still does fall under CBER-Vaccines division so the timeline/delays as stated by the Anon above in this specific division is very accurate and as he said this may likely end in the near future! OTAT is another specific Division of CBER, the timelines in this specific division is not really impacted!

Hope this helps!

Catherine, Thanks so much for the helpful input. 

My meeting request would be for a vaccine (not COVID).  If you or others have input for this Division, appreciate that also?

Thanks!

hey,

I have had recent experience with pre-IND meeting requests with CBER (OTAT/OTP specifically this year and last year) and in both instances CBER complied with the published/PDUFA-mandated timelines. Specifically, we received confirmation of WRO within 21 days of the meeting requests being submitted, and the WRO arrived within the 60 day timeline.

best,

Catherine

Hello,  Wanted to check with colleagues on this forum - I heard there is a long lead time for pre-IND meeting with CBER and not sure if it is true. 

Could you please reply if you have info/experience regarding timeframe between pre-IND meeting request received by FDA to the meeting date assigned (typically ~60d)?

Perhaps CBER is not keeping up with the ~60d timeframe per FDA's meeting guidance?

Thanks in advance!