CDER is making available the pre-recorded 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.
You may find the webinar links in the Resources for You box in the first column of the webpage.
- 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