Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations
This article was originally published in The Tan Sheet
Executive Summary
FDA better allocated resources for foreign inspections based on information European and Australian authorities shared in a two-year pilot program, including conducting good manufacturing practices inspections that met the needs of multiple agencies.
You may also be interested in...
FDA Closing Office In Jordan To Better Leverage Shrinking Resources
Opened as part of the globalization initiative, FDA’s presence in the Middle East and North Africa will shut down in late December in an apparent cost-cutting effort.
FDA Closing Office In Jordan To Better Leverage Shrinking Resources
Opened as part of the globalization initiative, FDA’s presence in the Middle East and North Africa will shut down in late December in an apparent cost-cutting effort.
FDA Could Publish Drug GMP Data To Nudge Manufacturing Improvements
Batch failure and other measures manufacturers commonly track could be aggregated into an industry-wide index FDA would use to help make inspection decisions. CDER compliance chief Howard Sklamberg says FDA wants more predictive measures to find quality issues, rather than lagging metrics such as recalls or adverse events.