FDA Webinar on Animal Drug Manufacturing System eSubmitter Tool

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The FDA is hosting a live webinar titled “Reporting 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 free software used to support the creation of secure electronic submissions to the FDA’s Center for Veterinary Medicine (CVM) for review. The webinar will take place from 1:00 p.m. to 3:30 p.m. ET on Wednesday, June 22, via Zoom, and aims to provide information on new improvements to the system.

In December 2021, the FDA announced an update to the eSubmitter intended to allow animal drug manufacturers to provide more comprehensive information about facilities, particularly about facilities that are actively used in their manufacturing processes, to provide supply chain data that enhanced the FDA’s ability to monitor the animal drug supply chain. This facility information must be submitted to the agency. This improvement was part of 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 collecting supply chain information; include live demos of users entering information into the various ADMS books and eSubmitter templates, focusing on 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 allow the CVM to quickly access information on animal-derived pharmaceuticals, active pharmaceutical ingredients, and the status of manufacturing sites, so that the agency can identify and address facilities. critical and animal-derived medicines affected by emerging diseases or natural disasters and collaborating with industry. identify solutions to potential animal drug shortages. This step brings CVM into line with other FDA Medical Product Centers that already require manufacturers of human drugs and biologics to provide facility and operational status information.

To register for the webinar, visit Webinar Registration – Zoom (zoomgov.com) and fill in the required fields. The webinar will be recorded and posted on CVM’s webinar webpage for those unable to attend the live session.

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