FDA Drug GMP Dispute Resolution Guidance Allows 10 Days For Objections
This article was originally published in The Tan Sheet
Executive Summary
FDA's dispute resolution pilot will allow manufacturers 10 days to challenge FDA inspection findings
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Dispute resolution guidance
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 The draft guidance, which was released in 2003, allowed only a 10-day period (1"The Tan Sheet" Sept. 8, 2003, p. 11).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...
Dispute resolution guidance
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 The draft guidance, which was released in 2003, allowed only a 10-day period (1"The Tan Sheet" Sept. 8, 2003, p. 11).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...
Dispute resolution guidance
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 The draft guidance, which was released in 2003, allowed only a 10-day period (1"The Tan Sheet" Sept. 8, 2003, p. 11).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...