Quality Metric Requirements Coming Soon for Drugmakers

Within one to two years, the FDA plans to require drug manufacturers to submit quality metrics data, such as batch failure rates or complaint data, to the agency. It will, in turn, use the data to target its inspections. One possible upside for manufacturers: better performing companies could face fewer inspections and faster regulatory approvals for certain applications. The agency initiative, unveiled in March, is starting to come into focus, with an FDA official telling Drug Industry Daily on Friday that the goal is to collect quality metric data from manufacturers to improve post-market surveillance on quality.

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