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 The draft guidance, which was released in 2003, allowed only a 10-day period (1"The Tan Sheet" Sept. 8, 2003, p. 11).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...
You may also be interested in...
FDA Drug GMP Dispute Resolution Guidance Allows 10 Days For Objections
FDA's dispute resolution pilot will allow manufacturers 10 days to challenge FDA inspection findings
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.