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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Combination Products Coalition wants guidance: More than half of surveyed members of the Combination Products Coalition, a group of companies in the drug, device and biologics industries, are dissatisfied with existing guidance from their trade associations and FDA on how to move combination products through the regulatory process, according to a CPC/Regulatory Affairs Professional Society (RAPS) survey presented March 26 by regulatory consultant Michael Gross at the Pharma MedDevice meeting in Philadelphia. Of the 32 companies surveyed, 78% were primarily focused on medical device development. Asked which topics they wanted guidance on, coalition members said they were most interested in documents on combination product clinical studies, good manufacturing processes, premarket approval submissions, cross-labeled combination products and adverse event reporting (1"The Gray Sheet" Feb. 18, 2008, p. 3)
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