Washington Wrap-Up
CDRH Misses User Fee, Amalgam Deadlines
Jan 17, 2012
In both the case of the user fees and dental amalgam, FDA did it again: It missed a promised deadline and, in doing so, demonstrated why its officials...
Limited Effectiveness Reported on Hip Bearing Combinations
Jan 17, 2012
A review of clinical trials, observational studies, and registries produced limited evidence on comparative effectiveness of various hip implant bearing...
The Growing Reduction of FDA
Jan 17, 2012
  To those who feel the increased presence of FDA investigators responding to commissioner Margaret Hamburg’s purported new emphasis on enforcement...
CDRH Report: The Barriers to Quality
Dec 19, 2011
A CDRH report says greater visibility on the agency’s expectations of device quality and properly aligning its regulatory approach are needed to...
Consumers Union Seeks Stronger Device Law
Dec 19, 2011
The Consumers Union (CU) is getting involved in the debate over the medical device approval process, asking Congress to bolster FDA’s standards for...
Kay Hagan Backs Legislation for Management Review Board at FDA
Dec 19, 2011
Sweeping new legislation drafted by Senator Kay Hagan (D-NC) in collaboration with the Biotechnology Industry Organization would establish a powerful...
CDRH Report Includes Promises to Improve Culture
Dec 19, 2011
As if to preempt external examination of its internal workings, CDRH included in a report on its premarket review programs a promise that it is going to...
FDA Needs to Examine Its Institutional Culture
Dec 19, 2011
The institutional culture at FDA has been gingerly discussed (if at all) for decades. As a major election year gets underway, the agency and its...
Medtech Attorney Pilot Urges Third Party Device Reviews
Dec 17, 2011
It’s time to revive the idea of third-party medical device reviews because CDRH “simply cannot acquire or maintain the levels of necessary...
Industry Rejects Funding FDA Bonuses with User Fees
Dec 13, 2011
An FDA proposal to apply user fee revenues to retention bonuses for its medical device employees got short shrift from industry negotiators at an August 31...