The latest news about the Internal Revenue Service does nothing to comfort those who have to routinely interact with the agency, but it does seem to tie in with other behaviors by the Obama administration, regardless of whether anyone at…
Tag Archives: CDRH
Bull in a China shop: Jeff Shuren at CDRH
September 27, 2012 – 7:53 PM
The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks…
Election 2012: Is Jeff Shuren’s job on the line?
September 4, 2012 – 6:56 AM
Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would…
Parallel review: Still not a big deal?
October 11, 2011 – 7:14 AM
Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they’ve tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a…
FDA’s resource dilemma: does more money equal more regulatory mischief?
September 23, 2011 – 7:21 AM
Much has been made of the slow-down in device approvals at FDA’s Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the…
The law of unintended consequences
September 7, 2011 – 6:22 PM
The title of this posting pretty much says it all, but I’m paid to tap out words on my keyboard. So here we go.
