FRequently Asked Questions

What are the criteria for a waiver intended for foreign clinical studies not conducted under an IND?

About the Author

Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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Pursuant to 21 CFR 312.120(c)(1), a waiver request is required to contain at least one of the following:

An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved;
A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
Other information justifying a waiver.

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