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Submission logistics: eCTD, preassigned tracking numbers, secure email and US agents
Summary
Panelists explained that preassigned tracking numbers (PTS/STN) are required for eCTD gateway submissions and should be requested no earlier than four weeks before the target date; CBER requires secure email for regulatory communications (effective 10/01/2018) and US agents have no formal regulatory qualifications but must be able to speak on behalf of sponsors without U.S. business presence.
Mara Miller told sponsors that a preassigned tracking number is required for original submissions sent via the electronic submission gateway (eCTD) and recommended requesting the number no earlier than four weeks before the target submission date. "So you'll need to request a pre assigned tracking number for any original submission that will be submitted via eCTD," she said, adding that CBER uses different numbers for meetings and INDs.
On communications, Mara stated that CBER requires secure email to protect proprietary information, a requirement effective October 1, 2018; she provided secureemailfda@hhs.gov as the contact to establish secure email. She also said there are no formal regulatory requirements for who can act as a U.S. agent, but sponsors should choose someone qualified to represent them.
