FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update

Stat News

23 August 2021 - The FDA and the drug industry have jointly agreed to create several new pilot programs aimed at speeding drugs to market for rare or previously untreatable conditions.

The agreement announced Monday lays out the improvements the FDA will make in exchange for the millions of dollars it receives from drug makers who pay fees when the agency reviews their applications for new drug approvals.

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Michael Wonder

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Michael Wonder

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Medicine , US , Orphan drug , Regulation