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Alias Born 01/28/2021

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Wednesday, 04/07/2021 9:24:47 AM

Wednesday, April 07, 2021 9:24:47 AM

Post# of 144813
IND Status Descriptions:

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Withdrawn
An IND application may be withdrawn by the applicant if development of the investigational product has been abandoned for any reason.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.
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