Dynamist Blog

Generic Backlog

I suspect this WaPost article was planted by FDA employees looking for a bigger budget, but it raises an interesting issue: Why is it taking so long to approve generic drugs? Marc Kaufman reports that the current backlog, more than 800 applications, is an all-time high. Unfortunately, he doesn't explain what the approval process entails--How much testing does a generic require anyway?--or what it's supposed to achieve.

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