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.