IndustryNews

June 6, 2022

Today the U.S. Food and Drug Administration is announcing a live webinar titled, “Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool.” The webinar is intended for animal drug manufacturers, US agents and consultants, and government agencies involved in the pharmaceutical supply chain. The eSubmitter tool is a free software used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine (CVM) for review. The webinar will take place from 1:00-3:30pm ET on Wednesday, June 22, via Zoom, and is intended to provide information about new enhancements to the system.

In December 2021, the FDA announced an eSubmitter update intended to enable animal drug manufacturers to provide more complete facility information, particularly about the establishments that are actively used in their manufacturing processes, in order to provide supply chain data that strengthened the FDA’s ability to monitor the animal drug supply chain.  This facility information is required to be submitted to the agency.  This enhancement was part of the ADMS, a project funded by The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency.

The ADMS webinar will explain the rationale for collection of supply chain information; include live demonstrations of users entering information into the various ADMS Books and eSubmitter templates, focused on the updated functionality; and will provide a live Q&A section where users can ask questions about the system and the new enhancement for sharing supply chain information.

Collecting facility information will enable CVM to rapidly access information on animal drug products, active pharmaceutical ingredients, and the status of manufacturing sites, so that the agency can identify and address critical facilities and animal drugs impacted by emerging diseases or natural disasters and collaborate with industry to identify solutions to potential animal drug shortages. This step brings CVM in line with the FDA’s other medical product centers that already require human drug and biologic manufacturers to provide facility information and operational status.

To register for the webinar, please visit Webinar Registration – Zoom (zoomgov.com)External Link Disclaimer and complete the required fields. If you would like to submit questions for the Q&A portion of the webinar in advance, please submit them to cvmesubmitter@fda.hhs.gov with the subject line “Live ADMS Webinar” by Tuesday, June 17.

The webinar will be recorded and posted to CVM’s webinar webpage for those unable to make the live session.

 

[Source: U.S. Food & Drug Administration]