Ready to Register? Attend FDA’s In-person or Online Event - Electronic Drug Registration and Listing Using CDER Direct - October 2, 2018

FDA CDER’s Small Business and Industry Assistance (SBIA) announces a new in-person and online event: 

Electronic Drug Registration and Listing Using CDER Direct

October 2, 2018

Silver Spring, MD

Registration and Agenda

This event is free to the public. You may attend in-person or via webcast.

Why Attend?

As the registration renewal and drug listing recertification period approaches, this event will educate and assist drug firms with the registration and listing process.

Experts and helpdesk technicians will be there in-person to answer regulatory and technical questions and assist with submissions.

Who Should Attend?

Those who want to learn more about drug registration and/or listing with CDER Direct.

Session Highlights

FDA will walk-through submissions and discuss the following:

Establishment Registration
Product Listing
Top 10 Errors
Compliance Cases
Listing Recertification
Labeler Code Request
National Drug Code Reservation
DRLS Compliance Program
503B Product Reporting for Compounding Outsourcing Facilities

Continuing Education (CE)

This event is eligible for up to six credits towards a RAC recertification.

Only in-person attendance will qualify for the CE. Attendance certificates are only available for two weeks after the event.