FDA Could Publish Drug GMP Data To Nudge Manufacturing Improvements
This article was originally published in The Tan Sheet
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.
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The Senate is expected to vote this week on the bipartisan compromise of the FDA user fee and reform legislation, which the House overwhelmingly passed in a voice vote June 20. Senate review of the bill will coincide with the Supreme Court’s decision on the health care reform law.
The type of incentive remains under consideration, but one suggestion is a grading system similar to what restaurants receive from local health departments.