As FDA looks to speed reviews even more, 2 policy experts want to restrict the price of drugs that win an accelerated OK
Even after the FDA added regulatory pathways for drug developers to win accelerated approvals for new drugs, the political pressure in Washington to speed up drug reviews continues to grow.
In testimony before a House subcommittee yesterday, FDA commissioner Scott Gottlieb assured lawmakers that biomarkers, new technologies and more efficient trial designs made it possible to shorten the regulatory process as he vowed to urge all the FDA to replicate the fast pace of the agency’s oncology division, which has reconfigured cancer drug development programs over the past 3 years.
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