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Workshop | Mixed

Event Title
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates
September 29, 2026

Date:
September 29, 2026
Time:
8:45 a.m. - 4:00 p.m. ET
Location:
Event Location
Attend In Person or Online
Virtual: Via Adobe Connect
In Person: FDA White Oak Campus

10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
United States


Agenda

Participants seeking a refresher on establishment registration and drug listing are encouraged to visit FDA Direct for tutorials and training videos prior to the workshop. From the Home Page Quick Links Section, select Tutorials > Webinars > Training Videos.

Register Here

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

Join SBIA as FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes. We'll also dive into compliance strategies for drug amount reporting requirements — a great opportunity to ask questions and hear directly from those working at the forefront of these issues.

To close out the workshop, we invite you to explore FDA's March 5th published final rule on Revising the National Drug Code Format and Drug Label Barcode Requirements, followed by an in-depth panel discussion where you'll have the chance to engage directly with subject matter experts, share your perspectives, and deepen your understanding of what these changes mean for your work.

Intended Audience

  • Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
  • Consultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.
  • Healthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.
  • Foreign drug manufacturers and importers that manufacture and import drugs for US commercial distribution. 

Topics Covered

  • Providing the latest updates for submitting accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.
  • Discussing drug amount reporting requirements and compliance outcomes.
  • Explaining the final rule Revising the National Drug Code Format and Drug Label Barcode Requirements and the future format of the NDC.

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

FDA Resources

Important Visitor Information

Food and Drink

  • Public meeting attendees may bring their own food and drink as campus access is restricted to the immediate meeting area.
  • For this event, light refreshments, sandwiches/wraps/salads are available during breaks and at lunch.
  • Restaurants near the FDA White Oak campus are available. Before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.
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