About FDA

Number of manufacturer adverse event (AE) reports received in the month

Dictionary: The FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.

These measures 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

Percent manufacturer AE reports received electronically in the month

Dictionary: The FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.