Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting for Regulatory Operations professionals is because it is so well attended by U.S. FDA staff members who participate both as speakers and fellow attendees. We particularly look forward to the “Ask the Regulators” sessions, where FDA representatives answer questions directly from the attendees. Following are highlights from the ‘Ask the Regulators’ sessions.
Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.
Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.
More than 3 million submissions were received via the ESG in 2015, and FDA representatives are estimating 7 million submissions for the year 2016. The volume increase is quite substantial considering 11.3 million submissions passed through the ESG in the previous 10 years (January 2006 to January 2016). Small user improvements planned by the FDA, and announced at DIA RSIDM 2016, will make life easier for sponsors who are growing more dependent on their Gateway accounts.
What has changed is the FDA’s methodology for collecting and organizing metadata associated with each application. The old M1 specifications arranged information in a flat structure, i.e., amendments could be related to other amendments. In the new M1 specifications, metadata is arranged in a hierarchy.