Industry: FDA Underestimated Burden of Metrics Reporting
This article was originally published in The Gold Sheet
Executive Summary
It will take more time and resources to set up and run quality metrics reporting programs than FDA estimated, industry says.
You may also be interested in...
FDA To Update Quality Metrics Guidance
It's the only addition to the agency's 2016 agenda.
FDA To Update Quality Metrics Guidance
It's the only addition to the agency's 2016 agenda.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.