Module 5 Presentations

18/07/2024

IND Annual Reports

IND application sponsors are expected to submit brief reports of the progress of the investigations conducted under their respective IND application (21 CFR 312.33) within 60 days of the anniversary date that the application went into effect. Federal regulations require sponsors to submit annual reports to FDA for all active INDs. Failure to do so may result in a sponsor being issued an IND reminder, pre-termination or termination letter.

The Organisation for Professionals in Regulatory Affairs

21

IND Annual Reports (cont’d.) IND annual reports are required to be submitted to FDA once a study is completed, inactivated or withdrawn. Description IND Status

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, an order issued by the FDA to the sponsor of an IND application to delay a proposed clinical investigation or to suspend an ongoing investigation. 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. An IND application may be withdrawn by the applicant if development of the investigational product has been abandoned for any reason. 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.

Inactive

Withdrawn

Terminated

The Organisation for Professionals in Regulatory Affairs

22

11