Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Wants To Release “Masked” Marketing Application Data To Researchers

This article was originally published in The Gray Sheet

Executive Summary

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.

Industry Questions Legality Of FDA Proposal To Release Masked Data

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.

Infuse Open-Access Project A Model For The Future? Medtronic Thinks So

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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032131

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel