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Monday, 10/12/2020 2:52:43 PM

Monday, October 12, 2020 2:52:43 PM

Post# of 144815
Hmmmm....so waggs may already know what this clinical hold is about...stay tuned!

"The clinical hold order may be made by telephone or other means of rapid communication or in writing. As soon as possible, and no more than 30 days after imposition of the clinical hold, a written explanation of the basis for the hold will be issued by FDA and sent to the applicant. The letter with the explanation will identify the studies under the IND application to which the hold applies, and will briefly explain the basis for the imposition of clinical hold."
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