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"The Food and Drug Administration (FDA) is so careful about the accountability of others that it ducks its own accountability altogether -- meaning that it takes six years longer to pass on its approval than it does for the same drug or medical device to be approved in other developed nations. That comes at a price: Two-thirds of the cost of a new drug is for it to meet the requirements of the FDA."
William P. Hoar
More Leeway for Regulators?, The New American, October 16, 1995.