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What steps will FDA take before imposing a clinical hold to protect subjects from investigator misconduct?
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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.

The general regulations governing clinical holds require that, where FDA concludes that there may be grounds for imposing a clinical hold, "FDA will, unless patients are exposed to immediate and serious risk, attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order." If possible, as in all cases where a clinical hold is considered, FDA will contact the sponsor and attempt to resolve the matter in a way that adequately protects study subjects before imposing a clinical hold, following the time frames described in companion guidances and regulations (e.g., Guidance with Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products and 21 CFR 312.42(e), respectively). In those cases where an inspection appears necessary to resolve issues, FDA will make every effort to ensure that the inspections are completed in a timely manner.

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