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  5. Drug Registration and Listing Staff
  1. Center for Drug Evaluation and Research | CDER

Drug Registration and Listing Staff

 

  • Agency lead for managing drug registration and listing database and policy issues.
  • Provides assistance to industry regarding submission of establishment registration and drug product listing data through the management of the electronic drug registration and listing (eDRLS) helpdesk.
  • Publishes the National Drug Code (NDC) Directory of all finished drug products available in the US.
  • Publishes the Drug Establishment Current Registration Site (DECRS) list of all currently registered drug establishments.
  • Provides drug registration and/or listing support to FDA surveillance programs and other Government Agencies.
  • Assesses and implements regulatory actions concerning violations of drug registration and listing requirements and facility obligations under the Generic Drug User Fee Amendments of 2012.