Assertion: submission | /r/HasProperty | withdrawn
Facets:
Source sentences:
text: If FDA does not receive a complete response to all deficiencies in the AI Request within 180 days of the date of the AI Request, the submission will be considered withdrawn and deleted from our review system.
text: Once a submission is received by a committee, you cannot publish or disclose it to any other person unless or until the committee has authorised its publication; nor can it be withdrawn or altered without the committee’s permission.
text: If the FDA does not receive a complete response to all deficiencies in the AI request within 180 days of the date of the AI Request, the submission will be considered withdrawn and the applicant will need to submit a new application if they still wish to pursue a CLIA waiver.