Celebrating 1H2011 s New Drug Approvals (sort of)
The FDA approved 20 new molecular entity NDAs in the first half of 2011, which is an impressive count. Of the 20, eighteen are new therapeutics (two were diagnostic reagents). This number of approvals is exciting, especially since in 2011 only 21 similar NDAs. This news was celebrated by some in the media as a turnaround for Pharm'a pipelines, andwelcomed more skeptically by others ...

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 ...

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. ...