FDA ESG Submission Protocol Options
The three different FDA ESG submission protocol options are described
below.
- FDA ESG Web Interface - The FDA ESG Web Interface sends submissions via
Hyper Text Transfer Protocol Secure (HTTPS) through a web browser according to
Applicability Statement 2 (AS2) standards. This protocol can be used to send
all types of regulatory submissions. See
FDA ESG Web Interface Electronic Submissions for information
about registering with an FDA ESG Web Interface protocol.
- Applicability Statement 1 (AS1) Gateway-to-Gateway - An electronic
submission protocol that uses secure email for communications. This protocol
can be used only to send AERS and AERS attachments. FDA ESG support for the
AS1 protocol will be phased out by December 2006. See
AS1 Gateway-to-Gateway Electronic Submissions for
information about registering with an AS1 protocol.
- Applicability Statement 2 (AS2) Gateway-to-Gateway - An electronic
submission protocol that uses HTTP/HTTPS for communications. This protocol can
be used to send all types of regulatory submissions. See
AS2 Gateway-to-Gateway Electronic Submissions for
information about registering with an AS2 protocol.
Determining the best of these options for your organization will be
influenced by the types of submissions to be transmitted, infrastructure
capabilities, and business requirements.
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