FDA seeks electronic reporting of drug stability tests

Watch for eStability reporting to become mandatory in the "next few years," said Catherine Hosage Norman, an expert in stability submissions and enthusiastic supporter of the FDA's eStability effort. Speaking at last night's PDA New England chapter meeting in Woburn, MA, she said the agency wants to improve stability data exchange. To some observers, however, "next few years" is a phrase that sometimes lacks meaning in regulatory initiatives, especially those in process for more than a decade. The FDA began its eStability reporting initiative in 1999.

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