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Posted On: 12/18/2023 11:39:12 AM
Post# of 154623
This may be applicable.
It's from an FDA "Regulatory Fitness in Rare Disease Clinical Trials" workshop last year.
If your response is complete, we will communicate within 30 days that either the clinical hold is removed, continued, or modified. Modification generally is to convert from a full hold to a partial hold, but sometimes it's to convert a partial hold to a full hold.
So technically the partial hold was likely converted. The info was included in our most recent 8K but I can understand not wanting to test the FDA's patience by PR'ing the info if the hold wasn't technically removed.
https://www.fda.gov/media/160997/download
It's from an FDA "Regulatory Fitness in Rare Disease Clinical Trials" workshop last year.
If your response is complete, we will communicate within 30 days that either the clinical hold is removed, continued, or modified. Modification generally is to convert from a full hold to a partial hold, but sometimes it's to convert a partial hold to a full hold.
So technically the partial hold was likely converted. The info was included in our most recent 8K but I can understand not wanting to test the FDA's patience by PR'ing the info if the hold wasn't technically removed.
https://www.fda.gov/media/160997/download
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