Multi-cycle product reviews
Executive Summary
FDA's investigation into reasons for multi-cycle reviews discovers that many cases were unavoidable, Commissioner McClellan tells drug delivery workshop. "In our preliminary results, it looks like in a lot of cases the multiple cycles were unavoidable," McClellan said. "New things may be discovered late in the development process," or unanticipated trial results may call for further evaluation, he explained. Nevertheless, the root cause analysis revealed that earlier communication between FDA and industry could have headed off a second cycle for a portion of product reviews, he said. The analysis into the causes of multi-cycle reviews will begin in earnest in fiscal year 2004 (1"The Pink Sheet" June 30, 2003, p. 5)...
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