10,000 drugs in the marketplace, 7,000 in development, and hundreds of applications to be reviewed each year: It's time to prioritize
By Kenneth I Kaitin and Christopher-Paul Milne
The priorities keep shifting, resources are static; staff is stretched thin, workplace tensions are thick; critics are many, friends are few. It's just another day at the office for the Food and Drug Administration.
Something has to change, but where to start? The FDA knows the answer: Prioritize. Development takes too long and costs too much because the processes, both regulatory and operational, haven't changed in 50 years. In response, the FDA launched the Critical Path initiative to establish this problem as a priority and has published a list of Critical Path opportunities. The trouble is that there are 76 items on the list. The FDA needs to "prioritize its priorities" and set the agenda for determining who should do what and ...
