FDA's Center for Drug Evaluation and Research, through its Small Business and Industry Assistance (SBIA) program, runs a hybrid workshop on drug establishment registration and listing compliance — , 8:45 a.m.–4:00 p.m. ET, in person at FDA White Oak or online via Adobe Connect.
Date and format
- Date: 29 September 2026, 8:45 a.m.–4:00 p.m. ET
- Format: hybrid — in person at FDA White Oak (Building 31, The Great Room) or online via Adobe Connect
- Organizer: FDA CDER, Small Business and Industry Assistance (SBIA)
- Registration: via FDA's workshop page; fee not stated in the sources reviewed
What it covers
FDA will share the latest updates on drug establishment registration and listing submissions, including current validation rules, and walk through the evolving compliance framework that shapes how industry engages with those requirements. A dedicated segment explains FDA's final rule revising the National Drug Code (NDC) format and drug label barcode requirement, closing with a panel discussion open to attendee questions.
Who should attend
FDA aims this at regulatory affairs and regulatory science professionals working on establishment registration and drug listing submissions and data compliance; consultants and vendors assisting industry with Structured Product Labeling (SPL) submissions; healthcare professionals using drug listing data and downstream databases; and foreign drug manufacturers and importers distributing product into the US.
FDA's SBIA program runs this kind of practical, compliance-focused workshop throughout the year, alongside CDRH's own public meeting on regulatory science priorities the same month; the full events directory lists every FDA session we have verified.
Frequently asked questions
When and where is FDA's Drug Registration and Listing Workshop?
29 September 2026, 8:45 a.m.–4:00 p.m. ET. It can be attended in person at the FDA White Oak Campus (Building 31, The Great Room, Silver Spring, MD) or online via Adobe Connect.
Who runs the workshop?
FDA's Center for Drug Evaluation and Research (CDER), through its Small Business and Industry Assistance (SBIA) program, which regularly hosts free educational workshops for regulated industry.
What does the workshop cover?
Updates on drug establishment registration and listing submissions, current validation rules, and FDA's final rule revising the National Drug Code format and drug label barcode requirement, closing with a panel discussion.
Who should attend?
Regulatory affairs professionals handling establishment registration and drug listing submissions, consultants and vendors supporting Structured Product Labeling (SPL) submissions, and foreign drug manufacturers or importers distributing into the US, per FDA's own workshop page.
Is there a fee?
FDA's page does not state a registration fee. It is not stated here because it was not confirmed in the sources reviewed — check FDA's own registration page before assuming it is free.
Sources & further reading
- FDA. Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates, 09/29/2026. fda.gov
- US Small Business Administration, Office of Advocacy. FDA's Drug Registration and Listing Workshop. advocacy.sba.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own page rather than a direct fetch, because this session's network egress could not reach fda.gov directly — confirm date, format and registration with FDA before making plans. Last verified 17 September 2026.
