FDA Wants To Release “Masked” Marketing Application Data To Researchers
This article was originally published in The Gray Sheet
FDA is seeking public feedback on a proposal to make masked and de-identified clinical trial safety and efficacy data from marketing applications available to outside parties for further analysis.
You may also be interested in...
Regulatory Briefs: Comment Period For Masked Data Release Reopened; Studies On 510(k), Post-Market Programs
FDA has reopened the comment period for its proposal to release masked trial data. The HHS Office of Inspector General released a study on FDA classification of class III pre-amendment devices. More regulatory news.
Device firms claim FDA does not have the legal authority to release masked and/or de-identified clinical trial data to researchers, as proposed in June. They also underscore the challenges in effectively masking device data, the risks to patient privacy and the hazards of analysis based on partial data.
Two independent analyses published on Medtronic’s Infuse biologic bone graft do not paint a positive picture for the device, but they do represent an important model for the future of open-access data analysis for drugs and devices, both Medtronic and academic proponents say.