Module 5 Presentations

18/07/2024

FDA IND & IND Amendment Review Timelines

Submission Types

FDA Review Timelines

Initial IND Application

30 calendar days review period from IND date of receipt.

Acceptability of approval of the IND may or may not come in writing after 30 calendar days.

Cross-reference IND Application

30 calendar days review period from IND date of receipt.

Protocol Amendments:

There is no 30 day window for FDA review.

New Protocols

FDA strongly recommended that you communicate with FDA and make sure they are OK with your new or amended protocol before going forward.

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Change in Protocols

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New Investigators

FDA must be notified within 30 days of enrolling the first subject.

Information must be submitted not more than every 30 days.

No FDA review window.

The Organisation for Professionals in Regulatory Affairs

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FDA IND & IND Amendment Review Timelines (cont’d.)

Submission Types

FDA Review Timelines

Information Amendments

Information must be submitted as needed but not more than every 30 days.

No FDA review window.

IND Annual Reports

Due within 60 days of the anniversary date that the application went into effect.

No FDA review window.

IND Safety Reports

No FDA review window.

The Organisation for Professionals in Regulatory Affairs

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