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| After submission of the IND, the sponsor must delay the use of the drug in human subjects for not less than 30 days from the date the FDA acknowledges the receipt of the application. An IND automatically goes into effect following this period unless the FDA notifies the sponsor that as a result of its review of the submission. it is waiving the period and the sponsor may initiate the study early or the investigation is being placed on a clinical hold. |
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dilemmaly(¿Õλ´ú·¢): ½ð±Ò+3, ¸ÐлӦÖú 2016-06-24 14:55:04
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dilemmaly(¿Õλ´ú·¢): ½ð±Ò+3, ¸ÐлӦÖú 2016-06-24 14:55:04
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