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Tag: FDA

FDA Internal Surgical Staples and Absorbable Collagen-Based Hemostatic Device Hearings: Consumer Representative Perspective

June 1, 2019 RSB Leave a comment

Disclaimer: Views in this post are my own and does not represent the views of the FDA. On May 30,…

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Posted in: Medical Harm Filed under: CDRH, consumer representative, FDA, internal surgical staplers, patient safety

FDA Breast Implant hearing- A Consumer Representative perspective

March 29, 2019 RSB 9d Comments

Disclaimer: Views in this post are my own and does not represent the views of the FDA. On March 25…

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Posted in: Medical Harm Filed under: BIA-ALCL, breast implants, consumer representative, FDA, surgical mesh

The Bleeding Edge Documentary on Netflix

July 27, 2018 RSB 1 Comment

I met The Bleeding Edge documentary film makers Kirby Dick and Amy Herdy in February 2016 in Washington, DC. They…

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Posted in: Medical Harm Filed under: bleeding edge documentary, FDA, medical device safety act, medical devices, patient safety

FDA fails to finalize proposed rule about generic medications- Still

March 27, 2018 RSB Leave a comment

On March 27, 2015 – three years ago today – I testified at the Food and Drug Administration about proposed…

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Posted in: Medical Harm Filed under: FDA, FDA failure, generic, medication, patient safety, Pliva v. Mensing

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