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Current Developments in the Automated NDA Field Alert Reporting Project
Session Chair(s)
Mark W. Browning, JD
Consumer Safety Officer, OMPQ, Office of Compliance, CDER
FDA, United States
This session will discuss the phase 1 pilot for development of an automated form used to submit data from the manufacturer to the Office of Regulatory Affairs and Office of Manufacturing and Product Quality.
Learning Objective : Discuss the new Automated NDA Field Alert initiative of the Office of Regulatory Affairs, Drug Surveillance and Reporting and Risk Science Intelligence and Prioritization teams within the Office of Manufacturing and Product Quality.
Speaker(s)
New ORA/CDER Field Alert Reporting Initiative
Karen E. D'Orazio
FDA, United States
Pre-Approval Manager, Office of Regulatory Affairs
Electronic NDA Field Alert Reports: Industry Perspective
Hitesh A. Patel
United States
New ORA/CDER Field Alert Reporting Initiative
Mark W. Browning, JD
FDA, United States
Consumer Safety Officer, OMPQ, Office of Compliance, CDER
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