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FDA Public Meeting about Risk of Gadolinium Retention from GBCAs

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July 21, 2017 – European Medical Authority takes action on Linear Contrast Agents.  Read all about it.

March 10, 2017 – European group recommends to stop using 4 linear GBCAs Read all about it.

February 27, 2017 – New Study Reports Gadolinium Retention in 70 Cases with Normal Kidney Function. Read all about it.

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On September 8, 2017, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) will meet to discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents (GBCAs) for MRI procedures.

During the Open Public Hearing (OPH) portion of the meeting, 75 minutes have been allotted to interested persons to present data, information, or views, orally or in writing.   The deadline for requesting time to speak has passed.  However, interested parties have until September 7, 2017 to submit electronic or written/paper submissions related to the issue of gadolinium retention.  Note that the Docket No. for the meeting is FDA-2017-N-1957 and it must be included on all submissions

An updated announcement about the meeting can be found here: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm571112.htm

CDER (Center for Drug Evaluation and Research) plans to provide a live webcast of the September 8, 2017 MIDAC meeting.  Information about the web address for the webcast will be made available at least 2 days before the meeting.  See the updated announcement for more information about the webcast.

The Medical Imaging Drugs Advisory Committee Meeting Briefing Document titled, Gadolinium Retention after Gadolinium Based Contrast Magnetic Resonance Imaging in Patients with Normal Renal Function, is available for download:  https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/MedicalImagingDrugsAdvisoryCommittee/UCM572848.pdf

Sharon Williams and Hubbs Grimm have submitted comments and supporting materials from The Lighthouse Project at GadoliniumToxicity.com for Docket No. FDA-2017-N-1957.


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