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.


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.