Integrated Assessment of Marketing Applications Virtual Workshop - 10/30/2020 - 10/30/2020 | FDA

Integrated Assessment of Marketing Applications Virtual Workshop - 10/30/2020 - 10/30/2020 | FDA

The U.S. Food and Drug Administration will hold a virtual public workshop on October 30, 2020, entitled New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.

The Integrated Assessment of Marketing Applications (Integrated Assessment) includes a new process and review template for the assessment and documentation of new drug product marketing applications—new drug applications or biologics license applications—in CDER. The purpose of the workshop is to solicit public feedback on characteristics of the Integrated Review document and how the Integrated Assessment can continue to support stakeholders’ needs.

The public meeting format will consist of a rotation of speaker presentations and panel discussions from FDA and external stakeholder representatives.

Please see the public workshop's webpage for additional information regarding the virtual public workshop, including examples of completed review documents, the link to the Federal Register Notice, and the registration link.