A formal FDA letter (Remove partial clinical hold) is issued to remove a clinical hold. Sponsors should submit a complete response to clinical hold to address any issues, so the review teams can process the request and formally lift the hold from the IND file.
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 03-Oct-2022 19:24
From: Anonymous Member
Subject: Partial Clinical Hold
This message was posted by a user wishing to remain anonymous
Hello: I hope you can answer a question I have on clinical holds. If a study has a partial clinical hold and then is completed, a final report is written and FDA is informed, is the partial clinical hold still active? Is it correct to assume the clinical holds are lifted as there is no additional action on the study conduct? What if a new study is submitted in the program. I can't find anything on the FDA website other than a sponsor has to satisfy FDA's issues for the hold before it can be lifted.