The issue of FDA days and non-FDA days in device applications has been one of the sticking points in the current round of user fee negotiations, and the agency's meeting minutes from the Aug. 24 meeting indicate that FDA may be willing to flex on this point. For those who are concerned about the prospects of cobbling together a user fee agreement to present to Congress by January, the development is an important one as it removes a major hurdle, although several remain. (Medical Device Daily)

  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 very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...

The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up because Steve Grossman of the Alliance for a Stronger FDA (Washington) raised the issue recently at the Gooznews blog. So let's take a quick look at this issue and examine the question of not just whether FDA is sourced to do this, but whether it should even consider such a task. As for resources, this is a no-brainer. While the...

We who scribble for a living find it easy to go off on those who do not, and today's bulls-eye is on the patent reform bill recently signed into law, the America Invents Act of 2011. One of the interesting things about H.R. 1249 is that it puts some of the fees collected by the U.S. Patent and Trademark Office in an escrow for Congress to decide whether to release to PTO. I've asked a number of people around Washington whether they think Congress can resist the temptation to write PTO an IOU and just keep the money, and almost...