Thursday, January 12, 2006

FDA Speeds Up Testing

LA Times:
Trying to increase the number of new drugs that make it to market, the Food and Drug Administration issued guidelines today allowing investigators to test minute doses of experimental drugs on people, to see if the results are promising enough to warrant full-scale clinical testing.

The FDA action was welcomed by scientific researchers and the industry, but some agency critics said they were concerned that it could increase hazards for volunteers, or facilitate the approval of drugs before their risks are fully understood.
Anything to speed up the molasses-like approval drug approval process that takes an average of 12 years and at a cost of $359 million for a company to get a new drug to market. (Although how much of that $359 million involves marketing and advertising I do not know)