FDA Approvals - FDA commissioner reaches out to small businessesThe head of the
FDA commissioner reaches out to small businesses
The head of the Food and Drug Administration pledged Friday to work more closely with small medical technology companies, which have spent the last year alleging that the agency is needlessly slowing approvals of new drugs and devices.
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. ...
Media White-wash Flawed Study Of Cancer Drug Approvals
The media's reporting on a recent study of the regulatory approvals of cancer drugs was uniformly, inexcusably sloppy. The New York Times' coverage was typical. It began:New cancer drugs are approved in just six months on average in the United States, half the time it takes for the same drugs to be approved in Europe, a new report finds.The analysis, published online this month by the journal ...