Industry Questions Legality Of FDA Proposal To Release Masked Data
This article was originally published in The Gray Sheet
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.
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The Institute of Medicine issued a draft framework for a study on expanding clinical trial data sharing and is seeking input from outside parties. The draft discusses how competing firms, disease advocacy groups and the media might responsibly use data shared by clinical trial sponsors.
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.
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.