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What are the criteria for a waiver intended for foreign clinical studies not conducted under an IND?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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