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Number of ONDQA-managed product quality meetings held with sponsors in the month (1)

Dictionary: Meetings, whether face-to-face or via telephone, with the Investigational New Drug (IND) sponsors and New Drug Application (NDA) applicants facilitate communication with industry to help ensure appropriate product development and address product quality issues. ONDQA participates in many industry meetings. Some, but not all, of these meetings are focused on chemistry, manufacturing, and controls or drug product quality topics and are led by ONDQA. This measure includes the number of meetings held with IND sponsor and NDA applicants for the month. This measure does not include industry meetings ONDQA participated in but are led by other CDER divisions (e.g., Office of New Drugs) or meetings that were scheduled for the month and later canceled.

This measure has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• FY 2011
• FY 2012
• All

Footnotes

• (1) Does not include industry meetings ONDQA participated in but managed by other CDER divisions.