FOIA

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FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the [...]

By |2012-11-13T22:43:22-05:00November 13th, 2012|FDA News|1 Comment

Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where's the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, [...]

By |2012-02-14T14:36:17-05:00February 14th, 2012|FDA News|2 Comments