Regulatory Trends, Real And Imagined
The FDA's chief drug regulator, Janet Woodcock, has made much of the spike in drug approvals during the first half of this year -- 20, compared with 21 for all of 2010. She cites these two data points as a trend. I can understand her self-serving optimism, but I am disappointed that the Wall Street Journal's Jonathan Rockoff and Ron Winslow seem to have bought Dr. Woodcock's snake oil. ...

Minnesota lawmakers critique FDA medical devices policy over IDEs
The medical device industry s favorite Congressional delegation has fired another salvo at the FDA approvals process. Minnesota s entire Congressional delegation sent a letter Thursday to U.S. Food and Drug Administration Commissioner Margaret Hamburg saying they are very concerned about the Investigational Device Exemption (IDE) review process. The delegation cites some of the industry s ...

The Truth About 2011's New Drug Approvals
As many new drugs were approved in the first half of this year as in all of last. That's good news, right? Maybe not.The Food and Drug Administration has approved 20 new medicines in the first half of this year, one short of of the total for all of 2010. Janet Woodcock, head of the FDA division that handles new drug approvals, said in Congressional testimony that this shows the FDA is not ...