Regulatory Open Forum

Dear Community,

Would appreciate pointers to the following items for an open IND of one investigational small molecule drug (one dosage form):

1). how does FDA define an indication for an open IND (with a broad indication) if one needs to add a second indication (narrow form of the broad indication) to it (same therapeutic area) -- are there specific guidance?

2). if second indication (narrow)  is related to the first indication of an open IND (broad indication; not approved via NDA) and is added via a new protocol submission to the open IND (first and second indication are in the same therapeutic area), are there any consequences to the open IND (undergoing studies)? 

Thank you

No.

(if it is the same dosage form, plus you may need to update your IB to support this narrow indication under the same IND.). The first indication is not approved so you are in exploratory phase.

Dear Community,

Would appreciate pointers to the following items for an open IND of one investigational small molecule drug (one dosage form):

1). how does FDA define an indication for an open IND (with a broad indication) if one needs to add a second indication (narrow form of the broad indication) to it (same therapeutic area) -- are there specific guidance?

2). if second indication (narrow)  is related to the first indication of an open IND (broad indication; not approved via NDA) and is added via a new protocol submission to the open IND (first and second indication are in the same therapeutic area), are there any consequences to the open IND (undergoing studies)? 

Thank you

Dear Community,

Would appreciate pointers to the following items for an open IND of one investigational small molecule drug (one dosage form):

1). how does FDA define an indication for an open IND (with a broad indication) if one needs to add a second indication (narrow form of the broad indication) to it (same therapeutic area) -- are there specific guidance?

2). if second indication (narrow)  is related to the first indication of an open IND (broad indication; not approved via NDA) and is added via a new protocol submission to the open IND (first and second indication are in the same therapeutic area), are there any consequences to the open IND (undergoing studies)? 

Thank you

Dear anon,

In my experience, FDA prefers that all indications that are the purview of the reviewing division should be in a single IND. For example, a broad spectrum antibiotic may under development for urinary tract infection, pneumonia and meningitis and all would be in a single IND since they would all be reviewed in the anti-infective drug product division. That would be still true if the product had an approved NDA for pneumonia and the UTI and meningitis indications were still under development.

Dear Community,

Would appreciate pointers to the following items for an open IND of one investigational small molecule drug (one dosage form):

1). how does FDA define an indication for an open IND (with a broad indication) if one needs to add a second indication (narrow form of the broad indication) to it (same therapeutic area) -- are there specific guidance?

2). if second indication (narrow)  is related to the first indication of an open IND (broad indication; not approved via NDA) and is added via a new protocol submission to the open IND (first and second indication are in the same therapeutic area), are there any consequences to the open IND (undergoing studies)? 

Thank you

Dear Community,

Would appreciate pointers to the following items for an open IND of one investigational small molecule drug (one dosage form):

1). how does FDA define an indication for an open IND (with a broad indication) if one needs to add a second indication (narrow form of the broad indication) to it (same therapeutic area) -- are there specific guidance?

2). if second indication (narrow)  is related to the first indication of an open IND (broad indication; not approved via NDA) and is added via a new protocol submission to the open IND (first and second indication are in the same therapeutic area), are there any consequences to the open IND (undergoing studies)? 

Thank you