Current Developments in the Automated NDA Field Alert Reporting Project

Track:
Pharmaceutical Quality

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
316

Room Number:
153C

Level:
Intermediate

Type:
Forum

Title:
Current Developments in the Automated NDA Field Alert Reporting Project

Chair(s):
Mark W. Browning, JD
Consumer Safety Officer, OMPQ, Office of Compliance, CDER
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
New ORA/CDER Field Alert Reporting Initiative
Karen E. D'Orazio
Pre-Approval Manager, Office of Regulatory Affairs
FDA, United States

Electronic NDA Field Alert Reports: Industry Perspective
Hitesh A. Patel
Product Manager, Pharma Technical Regulatory
Hoffmann-La Roche Inc., United States

New ORA/CDER Field Alert Reporting Initiative
Mark W. Browning, JD
Consumer Safety Officer, OMPQ, Office of Compliance, CDER
FDA, United States