OGD issues update on question-based review (QbR) submissions
This article was originally published in The Gold Sheet
OGD reports that in July 2007, more than 90 percent of ANDA submissions met the goal of including quality overall summaries that addressed all of the questions in the QbR. QbR is an assessment system focused on critical quality attributes which will assess a sponsor's implementation of the FDA's GMPs for the 21 Century and quality by design initiative
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