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FDA Launches Pilot eCopy Program To Eliminate Mailing CDs, DVDs, Flash Drives

If the pilot works out, sponsors will be allowed to submit premarket applications using a cloud server in addition to mailing paper copies of their documents.

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Mailing premarket applications on CDs, DVDs and flash drives alongside paper copies may become a thing of the past if a new US Food and Drug Administration pilot program is successful.

On 6 October, the FDA announced the immediate launch of the Electronic Delivery of Premarket Submissions Pilot Program, which will run for 90 days. Sponsors who want to help...

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