Regulatory Open Forum

Is there a requirement to submit updated Investigator's Brochure at the end of phase 1 discussion with FDA?

Updated IB should be submitted every year at the time of IND annual report! Or if significant change has occurred due to any ongoing animal studies or human studies, it should be updated right away!

Is there a requirement to submit updated Investigator's Brochure at the end of phase 1 discussion with FDA?

I understand that it should be updated at new information is available. My question is if FDA expect to see updated IB at the time of end of phase 1 meeting? or is it needs to be included with EOP1 meeting package?

My understanding is that IB is more for investigator to make unbiased risk benefit assessment and FDA will not be reviewing the IB for phase 2 study protocol review which is the objective of EOP1 meeting.

Updated IB should be submitted every year at the time of IND annual report! Or if significant change has occurred due to any ongoing animal studies or human studies, it should be updated right away!

Is there a requirement to submit updated Investigator's Brochure at the end of phase 1 discussion with FDA?

Updated IB should be submitted every year at the time of IND annual report! Or if significant change has occurred due to any ongoing animal studies or human studies, it should be updated right away!

Is there a requirement to submit updated Investigator's Brochure at the end of phase 1 discussion with FDA?