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FDA Approval rate

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from Galapagos forum:

The FDA Is Basically Approving Everything. Here's The Data To Prove It


Matthew Herper
FORBES STAFF

Remember when the FDA rejected drugs?

We just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.

As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.

Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.

www.forbes.com/sites/matthewherper/20...