CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Establishment Registration and Listing for Human Drugs
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
CDER is making available the webinar “Establishment Registration and Listing for Human Drugs” which will educate industry about a final rule The FDA recently published in the Federal Register amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. In addition, the rule makes certain changes to the National Drug Code (NDC) system. This rule modernizes our regulations and finalizes provisions that were proposed in 2006. This webinar will address the significant changes from the proposed rule and how the final rule will affect current industry operations.
Drug Registration and Listing System
Office of Compliance, CDER, FDA
David R. Joy
Senior Regulatory Counsel
Office of Regulatory Policy
Center for Drug Evaluation and Research
Food and Drug Administration
- DRLS Helpdesk: firstname.lastname@example.org
- SPL Helpdesk: email@example.com
- CDER Direct Helpdesk: firstname.lastname@example.org
- Electronic Systems Gateway Helpdesk: ESGHelpDesk@fda.hhs.gov
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
- Establishment Registration and Listing for Human Drugs
- Webinar (View Presentation)
- Drug Registration and Listing System (DRLS and eDRLS)
- Final Rule
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