Dispute resolution guidance
This article was originally published in The Tan Sheet
Executive Summary
Drug manufacturers are allotted 30 days to ask for clarification of a disputed scientific or technical issue under a guidance for industry on formal dispute resolution published in the Federal Register Jan. 12. The draft guidance, which was released in 2003, allowed only a 10-day period (1"The Tan Sheet" Sept. 8, 2003, p. 11). If FDA's Dispute Resolution Panel deems the issue worthy of review, the new guidance states the panel must schedule a meeting within 90 days of the request, rather than the indefinite amount of time allowed in the draft. The guidance also notes that during the process, "a manufacturer may include relevant information that was not presented during the inspection," as long as FDA determines that a reasonable explanation is given on why it was not presented during the inspection...
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