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FDA Approval Not Guaranteed


back to “Tips for Understanding Studies”

Many stories about drugs that are still in clinical trials include some estimate or projection of when the drug will be submitted to the Food and Drug Administration for approval, when the FDA might approve the drug, or when the drug might be available on the market. Many times, such projections are just shots in the dark. Until the trials are completed, until the data are submitted to the FDA for review, and until the FDA has made a decision, many of these predictions may be empty promises and may be proven wrong.

(See “How the media left the evidence out in the cold“)

If consumers hear or see stories that say a new drug “may be approved” or “could/should be approved” or “could be on the market” in some near time frame, they shouldn’t put too much stock in that prediction. The drug may never be approved and may never be available.

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