Stakeholders Ask FDA To Phase In Quality Metrics Draft Guidance

August 27, 2015 at 7:20 PM
Stakeholders advised FDA Monday (Aug. 24) to start small, and expand and evolve its requests for quality metric data from drug manufacturers as it learns whether specific data are effective at measuring quality at manufacturing facilities. Speaking at a public meeting held by the agency on draft guidance issued by FDA last month detailing quality metric data it was going expect from manufacturers, stakeholders also suggested the agency start by collecting data from high risk facilities; only requiring voluntary reporting...


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