The answer to your question is NO. You can inactivate your IND if you do not plan to enroll any patients under it, or have not had any activity within 2 years. Even in the inactive status, you can still allow a cross reference to the inactive IND (with data or information ...clinical or non-clinical) to support another IND. I have attached IND status positions for your review. This is the same as if you were allowing a cross reference to a DMF.
This does not apply if you withdraw your IND or terminate an IND.
| Active (ongoing) |
An IND application is in effect and the investigations are ongoing. |
| On Hold |
An active IND application where some or all of the investigations are on Clinical Hold. |
| Inactive |
An IND application may be inactivated upon the IND applicant’s request or FDA’s request. Inactivation of the IND application may occur if, for example, no subjects entered clinical trial(s) for 2 years or longer, or the IND application is on hold for 1 year or longer. An inactive application may be re-activated if activities under the IND application have restarted. |
| Withdrawn |
An IND application may be withdrawn by the applicant if development of the investigational product has been abandoned for any reason. |
| Terminated |
An IND application may be terminated by FDA if, for example, (1) human subjects are exposed to unreasonable or significant risk, or (2) methods, facilities and controls used for the manufacturing are inadequate to establish and maintain appropriate standards for quality and purity as needed for subject safety. Additional information on the grounds for termination of an IND application may be found in 21 CFR 312.44. |
I hope this helps...If you want definitive guidance, please call your project manager at FDA...
Eric
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Eric Floyd PHD,MBA,MS
Chief Science Officer and President, Compliance Services
Dohmen Life Sciences Services
Milwaukee WI
United States
Original Message:
Sent: 31-Oct-2016 10:26
From: Michael Hellerstein
Subject: Cross-referencing an inactive IND
We are considering placing an IND on inactive status, because we are not planning to run any more clinical trials under it. A partner organization is planning to perform its own clinical trials using our drug in combination with theirs under a new IND.
If we place our IND on inactive status, will that prevent us from allowing our partner to cross-reference the existing IND OS and amendments?
Thanks for your help!
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Michael Hellerstein
GeoVax, Inc.
Smyrna GA
United States
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