Regulatory Open Forum

Is there a policy from the FDA / DNP on multiple indications under one IND?
The situation: we have an existing IND for indication X and also an approval for indication X. The company now plans to explore a new indication Y and wants to submit the study protocol to the FDA for indication Y to the same existing IND for X.

Is that possible?
The Agency is requesting that each indication be placed in its own IND- are there guidance documents for this or a policy in place?

Your input is much appreciated.
Thank you!

Is there a policy from the FDA / DNP on multiple indications under one IND?
The situation: we have an existing IND for indication X and also an approval for indication X. The company now plans to explore a new indication Y and wants to submit the study protocol to the FDA for indication Y to the same existing IND for X.

Is that possible?
The Agency is requesting that each indication be placed in its own IND- are there guidance documents for this or a policy in place?

Your input is much appreciated.
Thank you!

New protocol can be submitted under existing IND if the new investigation is within the scope of the IND, we have occasionally added additional protocol with subtype of condition being studied for example, if your IND covers broader area of lung disease you could add individual protocol for diseases/conditions falling under one umbrella (COPD, BOS etc  or other specific subtypes) if the scope is similar. However, If the indication Y is completely different from X and changes the target population and risk/benefit ratio, as indicated by agency you will have to submit new IND [as suggested with cross reference to previous IND or package insert (if this is an approved product).

Is there a policy from the FDA / DNP on multiple indications under one IND?
The situation: we have an existing IND for indication X and also an approval for indication X. The company now plans to explore a new indication Y and wants to submit the study protocol to the FDA for indication Y to the same existing IND for X.

Is that possible?
The Agency is requesting that each indication be placed in its own IND- are there guidance documents for this or a policy in place?

Your input is much appreciated.
Thank you!

New protocol can be submitted under existing IND if the new investigation is within the scope of the IND, we have occasionally added additional protocol with subtype of condition being studied for example, if your IND covers broader area of lung disease you could add individual protocol for diseases/conditions falling under one umbrella (COPD, BOS etc  or other specific subtypes) if the scope is similar. However, If the indication Y is completely different from X and changes the target population and risk/benefit ratio, as indicated by agency you will have to submit new IND [as suggested with cross reference to previous IND or package insert (if this is an approved product).

Is there a policy from the FDA / DNP on multiple indications under one IND?
The situation: we have an existing IND for indication X and also an approval for indication X. The company now plans to explore a new indication Y and wants to submit the study protocol to the FDA for indication Y to the same existing IND for X.

Is that possible?
The Agency is requesting that each indication be placed in its own IND- are there guidance documents for this or a policy in place?

Your input is much appreciated.
Thank you!

Is there a policy from the FDA / DNP on multiple indications under one IND?
The situation: we have an existing IND for indication X and also an approval for indication X. The company now plans to explore a new indication Y and wants to submit the study protocol to the FDA for indication Y to the same existing IND for X.

Is that possible?
The Agency is requesting that each indication be placed in its own IND- are there guidance documents for this or a policy in place?

Your input is much appreciated.
Thank you!