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Yale CRRIT Researchers Examine Cancer Drug Guidelines and FDA Approvals

Drugs for serious or life-threatening diseases can receive expedited U.S. Food and Drug Administration (FDA) review, allowing patients to receive faster access to promising new treatments. Under the expedited review pathway of accelerated approval, drugs can be FDA-approved based on surrogate markers or proxy measures such as changes in imaging or lab tests that are “reasonably likely” to predict whether patients improve in how they feel, function, or survive.

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