FDA streamlining drug approval process

Some time ago the FDA kicked off a program to speed the movement of new drugs through the FDA approval process. The project, called the Critical Path Initiative, proposes to streamline the process in several ways. For example, drug makers would now get permission to test a drug in ongoing trials for benefits they hadn't originally envisioned. The Critical Path process would also allow pharmaceutical companies to use predictive markers rather than testing results to evaluate new drugs. To facilitate this aspect of the initiative, the NIH and CMS are paying researchers to identify good markers.

Patient advocates are fighting for these changes, given how long it currently takes potentially helpful drugs to reach the market. After all, it takes an average of seven years and $868 million to bring a drug to market, according to the industry-backed Tufts Center for the Study of Drug Development. But other researchers warn that science doesn't support more widespread use of markers, which can don't always work as expected.

To learn more about the approval initiative:
- read this Baltimore Sun article

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