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Safety Versus Speed — Drug and Device Approval Options

Summary:
Safety is relative, and whatever quantum of safety we achieve comes with its own perils. The federal government, through agencies like the Food and Drug Administration, strives for — but cannot guarantee — patient safety. There’s a terrible tradeoff between relative safety and opportunities to save the dying, heal the sick, and relieve those in pain. Ban a drug, or take years approving it, and those it could help may suffer. At present, FDA policy applies uniformly to the entire population. Once a drug is approved, everyone can get it (perhaps with a licensed provider’s signature). Before approval, no one...  Continue reading: Safety Versus Speed — Drug and Device Approval Options

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Safety is relative, and whatever quantum of safety we achieve comes with its own perils. The federal government, through agencies like the Food and Drug Administration, strives for — but cannot guarantee — patient safety. There’s a terrible tradeoff between relative safety and opportunities to save the dying, heal the sick, and relieve those in pain. Ban a drug, or take years approving it, and those it could help may suffer.

At present, FDA policy applies uniformly to the entire population. Once a drug is approved, everyone can get it (perhaps with a licensed provider’s signature). Before approval, no one... 

Continue reading: Safety Versus Speed — Drug and Device Approval Options

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