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August 26, 2015 - Revised: 10.05.15

Pre-submission Review Process (CM00013)

Due to multiple requests for assistance with Technical Assessments (TA), the MolDX Team is pleased to announce the development of the Pre-Submission Review Process. This new process offers developers the opportunity to receive feedback on dossier materials prior to a TA submission. Although the Pre-submission Process does NOT affect the requirements or review timeline for a TA, the Team hopes the information obtained through the Pre-submission Review will be used to prepare a comprehensive TA submission package and reduce unsuccessful TA submissions.

To request a Pre-submission Review, please follow the steps outlined in the instruction document, complete the form, collect appropriate reference and study material per the instructions and submit your request.

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