Saturday, January 14, 2006

Research: FDA moves to promote 'efficiency' of early drug research

Is this a good idea? From the NYT:
In part, the suggestions detail ways to make small batches of experimental compounds to test tiny doses in people. Previously, researchers had to meet costly requirements for large-scale manufacturing to do early tests, Food and Drug Administration officials said.

Studying small doses can be useful because new technology lets scientists see if an experimental drug behaves as expected in the body and reaches its intended target, like a tumor, officials said. Patients should be spared side effects at that stage because doses are small, they said.

Link (free reg req'd)

1 comment:

mdmhvonpa said...

Hmmm, reminds me of the 'Fast Track' in the FDA ... NOT a good thing.