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Electronic Submission Gateway

Electronic submission standards are evolving and may not be clearly established for all FDA groups and divisions. The common electronic submission gateway (ESG, see Chapter 1 FDA Documents) is sometimes problematic. [Pg.5]

YOU ARf ENTERING Tl- FDA ELECTRONIC SUBMISSIONS GATEWAY TEST ENVIROWENT. THIS ENVIRONMENT IS TO BE USEO FOR TEST SUBMISSIONS OU.Y. [Pg.20]

The date and time stamp contained in this message conveys when CBER received your submission from the Electronic Submission Gateway. If your submission was received at CBER after 4 30 PM EST, the official receipt date for the submission is the next government business day. [Pg.35]

Applicability Statement 1 (AS1) Gateway-to-Gateway is an electronic submission protocol that uses secure e-mail for communications. [Pg.16]

One of the primary differences between the FDA s and EPA s rules is the creation of the CDX. The EPA s OEI is currently developing the specifications for a CDX that will serve as the Agency s gateway for electronic documents received by the EPA. CROMERRR reports that with respect to the electronic document submission addressed by today s proposal, CDX functions will include the following ... [Pg.1072]

See other pages where Electronic Submission Gateway is mentioned: [Pg.20]    [Pg.25]    [Pg.32]    [Pg.57]    [Pg.73]    [Pg.74]    [Pg.20]    [Pg.25]    [Pg.32]    [Pg.57]    [Pg.73]    [Pg.74]    [Pg.10]    [Pg.24]   


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