
Speedy Drug Approvals Have Become the Rule, Not the Exception
A majority of recent drug development has been in therapies that qualify for at least one special approval pathway that Congress has passed over the past few decades for important drugs that treat life-threatening or rare diseases.
Congress has over the past few decades passed a series of special approval pathways for important drugs that treat life-threatening or rare diseases. This week, a new bill introduced in the House could add 2 more.
You might expect these existing special programs to represent a small fraction of new and unusual drugs. But data from the FDA show that a majority of recent drug development has been in therapies that qualify for at least one of these programs. About a third of recently approved drugs qualify for 2 more of 5 special approval programs.
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