Mammography advisory committee
This article was originally published in The Gray Sheet
Executive Summary
FDA National Mammography Quality Assurance Advisory Committee will convene April 19 to discuss whether images from reconstructed, compressed digital data, and digitized film-screen mammograms can be used for primary interpretation or storage. CDRH Director David Feigal touched on the issue at a recent oncology meeting: "As we increasingly use telemedicine and data compression techniques to be able to squeeze data-dense images into telephone lines or high-speed lines and open them back up on a remote computer," FDA needs to ensure that information is not altered or lost. The committee also will address ways to reduce regulatory burdens for MQSA facilities and discuss revisions to the compliance guide...
You may also be interested in...
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials
Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.