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This article was originally published in The Gold Sheet

Executive Summary

...draft guidances from FDA have prompted industry to urge a more flexible regulatory approach in this area. The comments on the new oral/nasal inhalation dosage form guidances represent a consensus industry view of "good practices" for CMC regulatory policy development. Industry is concerned that FDA is taking an overly conservative posture that would hamper technological innovation. FDA, on the other hand, points to the susceptibility of inhalation products to quality problems as justifying a conservative approach. A recent public workshop on inhalation product CMC fuels the debate. (An analysis of inhalation product recall and GMP compliance problems over the past five years is included.)

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