Revised Draft Quality Metrics Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA has issued a revised draft guidance on submitting quality metrics data that reflects input from industry on the original July 2015 draft. The new draft provides: ● for the adoption of a phased-in (voluntary) approach ● a reduction in the number of data elements requested ● for both product reports and site reports ● modifications to the quality metrics data definitions ● the addition of clarifying examples for the definitions ● the addition of comment fields, and ● clarification of special considerations for non-application and OTC [over-the-counter] product reporting. FDA also has a webinar available on its quality metrics webpage discussing the draft. [See IPQ Aug. 23, 2015 and IPQ September 22, 2015 for an analysis of the draft and industry’s feedback.]
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