September 26, 2017

Drug Listing Certification is Coming

The FDA is holding a free meeting on October 5, 2017 titled Electronic Drug Registration & Listing Using CDER Direct. This in-person and on-line event is intended to educate and assist all drug firms with the registration and listing process. Each session will focus on a specific submission (Establishment Registration, Product Listing, Listing Recertification, Labeler Code Requests, 503B Product Reporting) and walk through the creation and submission of each using FDA's free authoring tool: CDER Direct.

Additionally, for those who attend in person, experts and helpdesk technicians will be on hand to answer regulatory and technical questions, and assist with submissions.

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