FDA to identify research projects
WASHINGTON (AP) -- Federal regulators, working with patients, academics and pharmaceutical companies, are listing dozens of potential research projects they believe would help shorten the time it takes for new drugs to reach patients.
The release this week of the Food and Drug Administration list of roughly 75 projects comes two years after the regulatory agency first announced it would identify ways of modernizing the drug development process under its so-called "critical path" initiative. The name refers to the journey a drug takes from laboratory to patient.
The FDA has said that it wants to take some of the guesswork out of the job of developing and testing drugs, as well as medical products, and make the process more predictable and less expensive. If successful, FDA officials and others hope the initiative will refill a pipeline that's slowed to a dribble.
With more than nine out of 10 experimental drugs failing when tested in humans, the number of innovative drugs reaching the market hit a 20-year nadir in 2004 -- even as pharmaceutical research-and-development spending has increased, according to the FDA.
Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said Tuesday that the critical path list "will highlight areas where we think better scientific tools can continue to improve the way that new drugs are tested." His remarks were prepared for the International Good Manufacturing Practices conference at the University of Georgia College of Pharmacy in Athens.
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