Will it Get Tougher to Bring New Diabetes Medications to Market?

The Food and Drug Administration is considering tougher standards for new and current diabetes drugs, raising concern in the pharmaceutical industry that the agency may ultimately raise the time and cost needed to approve of a wide array of new drugs. The FDA is weighing whether to insist that new diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar. A shift away from current research benchmarks, known as surrogate endpoints, might change the entire framework of drug approval because research on most medicines — from anemia to cancer drugs — relies on such interim measures. Read more in the article from the Wall Street Journal online.

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