Frequently Asked Questions

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

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Guidelines & Standards

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.