DIA RSIDM 2025: FDA Call for Topics

Welcome to our 2025 Regulatory Submissions, Information, and Document Management (RSIDM) Forum Call for Topics brainstorming activity! The topics listed below are specific to content relating to the US Food and Drug Administration (FDA).

By brainstorming together, we aim to gain a better understanding of your professional needs and the type of content DIA, and the FDA should focus on for the DIA 2025 RSIDM Forum program agenda.

Please note: Submission of a topic suggestion is not related to chairing a session or speaking at the RSIDM Forum and does not count as an abstract submission. Please refer to our call for abstract process if interested in submitting a presentation, session, or short course abstract to our 2025 forum.

What topic(s) from the FDA would you like to see at DIA’s RSIDM Forum in 2025?

Question Title

* 1. Please select the topic(s) you would be interested in hearing about at the forum (select all that apply). If something is not listed, please add to the “other” field:

Challenges of current FDA forms to the FDA process

Data and technology-focused commitments in PDUFA VII

eCTD related guidance and specifications

Electronic Common Technical Document (eCTD) (general)

Electronic System Gateway (ESG)

End-to-end submission process

FDA AI policy and guidance updates

FDA “Ask the Regulator” session (Q&A with the regulators)

FDA CDER NextGen Portal FDA forms

FDA CDER’s NextGen Portal

FDA’s Data Modernization Action Plan (DMAP), Technology Modernization Action Plan (TMAP), and Enterprise Modernization Action Plan (EMAP)

FDA ESG NextGen Portal Implementation

FDA processing challenges

FDA's approach to IDMP standards

FDA’s current required data standards for regulatory submissions

FDA’s perspective on best practices for successful regulatory submissions

FDA’s target timeframe between key milestones and notifications

FDA’s target timeframe for the expected submission upload duration

FHIR standards and implementation (The future of SPL submission)

ICH Pharmaceutical Quality Knowledge Management System (PQ KMS) Initiative Update

International work-sharing initiatives and collaborations

Knowledge-Aided Assessment and Structured Application (KASA)

M11 Guidance development for common protocol template

Pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) project and initiative updates from the FDA

Regulatory electronic submission process

Research IND Application Builder

The future of regulatory submissions: opportunities and challenges

Other Topics (Please note - the suggestion may not exceed 300 characters)