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www.fdanews.com/articles/167553-guidance-outlining-up-to-10-quality-metrics-expected-by-years-end-fda-official

Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official

October 3, 2014

The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. The selection of 10 metrics could present a significant challenge for industry, however, which has called for collecting only four metrics.
Drug Industry Daily