Drug Registration and Listing Workshop Recordings Available

If your email program has trouble displaying this email, view as a webpage. December 1, 2020 CDER Small Business and Industry Assistance Learning Library on YouTube Dear Colleague, Recordings and slides are now available CDER SBIA Drug Registration and Listing Workshop. Please feel free to share via email or on social media with interested colleagues. Drug Registration and Listing Workshop Recordings  Labeler Code Request  How to submit a Labeler Request Structured Product Labeling (SPL) using CDER Direct How to update an existing Labeler Code Request SPL Why a labeler code is inactivated by FDA Establishment Registration Establishment registration renewal Establishment de-registration US Agents and Importer requirements for foreign establishments Drug Listing How to reserve an NDC prior to drug listing How to submit a Drug Listing SPL using CDER Direct How to update an existing Drug Listing SPL, including discounting a drug Establishment Registration and Drug Listing Compliance Program Compliance case process and manual overrides Case Study of a violation FDA's Drug Listing Inactivation Project Download Slides The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn If you have comments or questions, contact CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.

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