The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).” In this guidance, FDA is providing information on How ANDA applicants and holders should monitor for changes to RLD labeling: The sponsor […]
ESG will introduce a web interface to submit and access tickets to all ESG users. This new web interface will allow ESG users to submit tickets, view ticket updates, view the history of all tickets (including closed tickets), and access FAQs based on the ticket Request Type. 1. ESG users may continue to send emails […]