Allison Steffen
The recent DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference offered many practical insights for regulatory submission professionals. As an attendee, I found the discussions and updates from the FDA particularly helpful, offering a glimpse into the future of regulatory submissions.
eCTD 4.0 and Its Implications
A significant highlight was the FDA's announcement on the transition to eCTD 4.0. They expect to potentially start accepting voluntary submissions by the end of June 2024. This move, focusing initially on new applications, underscores the agency's commitment to leveraging technology for more efficient and effective submissions.
FDA also announced that the opportunity to submit sample submissions in eCTD 4.0 for agency review and feedback should become available this summer. Make sure to keep an eye on FDA’s eCTD Sample submissions webpage for an official announcement when this goes live.
While it may be a while before your organization is ready to submit in eCTD 4.0 format, it is never too early to begin educating your team. Stay tuned for future updates from WAYS, as we will be paying close attention to the new process and sharing helpful hints on staying compliant.
Next Generation ESG Portal
The introduction of the ESG Next Gen Portal marks another leap towards digital transformation, and the new portal promises to streamline submission processes significantly. With user acceptance testing slated for March/April, the agency plans to implement it by FY2025 per its PDUFA commitments. During the session, concerns were raised about two-way communication and how it will work when sponsors use a vendor. The FDA noted that two-way communication is not within the scope of the first release, but they are considering that factor in their development efforts.
Structured Data and Project PRISM
The transition toward structured data, including the use of Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) and the initiation of Project PRISM, represents a significant shift in regulatory submissions. The aim is to decrease reliance on PDF documents by migrating information into standardized digital formats, like SPL or CDISC datasets, and facilitating easier analysis of raw data, especially that found in tables within Module 3. HL7 FHIR is a coding language designed to standardize and enhance the format of this raw data.
Project PRISM, still in its nascent stages, explores the potential for interactive reviews between the FDA and sponsors within a cloud-based environment. It signals an innovative step forward that stakeholders should closely monitor.
IND Safety Reporting
The shift to XML IND safety reports, represents a significant change in how safety data is reported. The announcement of official acceptance of voluntary submissions in this new format could be coming as soon as March 2024. Once the new format begins to be accepted, there will be two years before this is mandatory. Make sure to keep an eye on the FAERS Electronic Submissions page for the official announcement. With post-marketing safety reports already live in this format as of January 2024, we are seeing great progress.
Panel Q&A Insights
The Panel Q&A sessions provided valuable insights into the FDA's expectations and preferences on everyday eCTD scenarios. A few key takeaways are highlighted below:
Sponsors should complete the establishment information on the 356h correctly. The agency doesn’t want it submitted as a PDF attachment.
CDER was asked about cross-application links. They responded that they generally accept cross-application links, but sponsors should speak with their project manager first to get their perspective. Also, if sponsors are creating them, you MUST have the cross-reference sections filled out on the 356h.
Sponsors must use a fillable version of the 2252 Annual Report form.
For DMF Form 3938, a fillable form is also preferred. If you don’t have a fillable version, it will not be a validation issue under the current criteria.
Some attendees expressed frustration at the new rejections due to Supplement Numbers on 356h not being populated correctly. The FDA noted they will evaluate updating the validation criteria to add this.
FDA seems to view the 356h as the source of truth for most administrative information (Application type/subtype, etc).
If the Administrative metadata and 356h form Submission Type/Subtype are not aligned, it’s frustrating for the agency, but they are unlikely to reject it unless you have an invalid Submission Type/Subtype combination.
The agency mentioned that guidance is planned this year for submitting BIMO to CBER.
Concluding Thoughts
The DIA RSIDM Conference was an invaluable opportunity to hear directly from the FDA. The overarching message was that changes are coming that will bring electronic submissions into more modern, updated formats and technologies. It was also a great opportunity to network with peers and better understand how sponsors are preparing and responding to the planned changes. The months ahead will be a pivotal period of adaptation and innovation, setting the stage for more streamlined and technologically advanced regulatory submission processes that promise to reshape our industry's future.