Module 5 Presentations

18/07/2024

IND Components (cont’d.)

Module 4 (Nonclinical) ● Need all nonclinical reports to be submitted and all nonclinical datasets – Unaudited draft toxicology reports can be submitted in the IND but FDA expects that the final reports are available upon request as final, fully quality-assured documents within 120 days from clinical study start. ● Nonclinical literature references Module 5 (Clinical) ● Protocol ● Investigator information

● Literature references to Investigator Brochure ● Clinical Study Report & dataset (if applicable)

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IND Amendments Once an IND application is in effect (meaning that FDA has reviewed the IND and deemed it is safe to proceed, ie., approved the IND), the sponsor of the IND may amend the application, to ensure the clinical investigation(s) are conducted according to the protocols included in the IND application. An open or active IND can contain multiple protocols ranging from Phase I to Phase IV. IND amendments can include: ● Contact changes

● CMC updates ● Label changes ● New/ amended protocols ● Investigator updates ● Safety reports

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