Medical Device Dispute Resolution Panel Gains Two Standing Members
This article was originally published in The Gray Sheet
Executive Summary
The appointment of Warren Browner, MD/MPH, to the Center for Devices & Radiological Health's Medical Device Dispute Resolution Panel (MDDRP) completes the panel's current roster
You may also be interested in...
FDA Acts Quickly On Lifecore’s Intergel PMA Following Dispute Resolution
FDA has approved Lifecore Biomedical's Gynecare Intergel adhesion prevention solution for the indication sought by the company with the addition of several warnings and contraindications
Lifecore Intergel Approvable Despite FDA Objections, MDDR Panel Says
Lifecore Biomedical's Gynecare Intergel adhesion prevention solution appears closer to FDA approval following a determination by the agency's Medical Devices Dispute Resolution Panel (MDDRP) that the firm demonstrated a statistically significant treatment effect.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.