Election Results & Impact on FDA - Nov 13, 2006

On the very next day AFTER the election, FDA announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
(Do you think the timing is coincidence?)

A Democratic-led Congress appears willing to make FDA improvements, starting by shuffling a few key committee chairmen.

Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.

"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei , a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association.

What does this mean for us?
Probably a tougher FDA. Stay tuned.

Read FDA’s Press Release outlining their new action plan as well as a news story published in the Boston Globe with some analysis of the impact this will have on industry.

Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 972 clients since 1996

Today is the final day to register for our last GMP Boot Camp in 2006 - Nov 15 - 16 in Irvine, CA. Only five seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

Please forward this post to others in your organization who might benefit.