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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 the agency eliminate the hassle of mailing in premarket applications on CDs, DVDs and flash drives can volunteer for the pilot program

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