premarket review

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FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI).  The experts  Read more

By | 2018-07-10T13:10:44+00:00 March 29th, 2013|FDA News|13 Comments

ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line - medical devices are big business bringing over $100 billion-a-year Read more

By | 2012-05-10T16:05:00+00:00 May 10th, 2012|Featured|2 Comments