Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process

The Hill

23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program in response to the HIV epidemic.

The accelerated approval program is a mechanism that permits conditional approval of a new drug that treats a serious medical condition and fills an unmet need based on its impact on a surrogate outcome.

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Michael Wonder

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Michael Wonder