Too Fast and Furious?
Expedited regulatory approvals bring medicines to market faster – but are they the right drugs?
Stephanie Sutton |
Several drugs regulators across the world have developed specialized administrative pathways designed to accelerate the development and review of innovative new drugs for important unmet medical needs. But is speeding up the approval process always a good thing? Some researchers are not entirely convinced of the benefits. A team led by Aaron Kesselheim, an associate professor of medicine at Harvard Medical School in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women’s Hospital, has investigated the trends in the growing utilization of the US FDA’s expedited development and approval programs (1).
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