DIA’s 2022 Regulatory Submissions, Information, and Document Management (RSIDM) Forum was DIA’s first conference allowing in-person attendees since the start of the COVID-19 pandemic. While many attendees still chose the virtual attendance option, it was great to see so many familiar faces in person after such a long hiatus. DIA did a fantastic job leveraging technology to make the sessions accessible for both in-person and virtual presenters and attendees.
The conference theme was the coming shift in how drug development information is submitted to regulatory authorities, moving from “electronic paper” (i.e., PDF documents) to structured data. Many sessions focused on how industry and regulators could benefit from a data-centric approach over the current document-centered paradigm. Although a true shift to structured data is still years away, it’s clear that the gears are already turning. It was interesting and insightful to hear what both industry and the US Food and Drug Administration (FDA) are already doing to advance these ideas. I look forward to how things will continue to unfold over the next few years.
Ask the Regulators Sessions
As always, one of the best reasons to attend this meeting is the strong participation from FDA regulators. These regulators participated as speakers in several sessions, including two “Ask the Regulators” sessions which were among the most popular. Here are some of the most interesting and/or useful tidbits I took away from FDA’s various presentations at RSIDM.
- Submissions to CDER have doubled since 2000.
- >90% of submissions are now in eCTD format via the ESG, with most of the remainder (Investigator INDs) coming via the CDER NextGen Portal.
- FDA’s module 1 DTD v2.01 is no longer supported as of March 01, 2022.
- FDA currently plans to begin accepting eCTD v4.0 submissions in 2023.
- Initially, FDA will only accept new initial applications (ANDA, BLA, DMF, IND, NDA) in this format, with transitions for existing applications from v3.2.2 to v4.0 coming in a subsequent phase of the rollout.
- Expect at least a 2-year period where both v3.2.2 and v4.0 submissions are accepted before v.4.0 is mandated.
- Two-way communication between the agency and sponsors will not be enabled initially but will be enabled in a subsequent phase of the rollout.
- For CBER, non-clinical study datasets must be provided in CDISC SEND format beginning March 23, 2023.
- FDA does not provide a free SEND validation tool. FDA uses the validation tool from Pinnacle 21.
- Validation criteria 1306 and 1323 will be elevated to high severity as of March 01, 2022.
- After this date, these errors will result in a rejection of your submission.
- Duplicate sequence number (validation criteria 1697) remains the most common reason for technical rejection.
- Validation errors 1734 and 1789 are the most common study data-related errors resulting in rejections.
- FDA forms.
- FDA again confirmed it extracts data from their fillable forms to automate the processing of eCTD submissions.
- FDA also confirmed that digital signatures cannot be used with their fillable forms due to the enabled security features.
- It is acceptable to submit 2 copies of the form: a signed, scanned version and a completed, fillable version.
- Always check the FDA forms web page for the most current version of any form.
- eCTD sequences larger than 10 GB may be submitted via the ESG or via physical media.
- There is no requirement for an IND’s serial number and sequence number to match.
- Yes, you should still notify the district office by letter that your marketing application will be submitted to FDA. See section 3.1.9 of the eCTD Technical Conformance Guide for more details.
- Bioresearch Monitoring (BIMO) inspections.
- 2020’s inspections total was the lowest since at least 2011.
- Only 14% of inspections were for cause in 2020.
- 70-80% of inspections are within the US each year.
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