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Regulatory Focus™ > News Articles > Science & Technology: FDA Requirements for New Molecular Entities for the Treatment of Cancer

Science & Technology: FDA Requirements for New Molecular Entities for the Treatment of Cancer

Posted 01 July 2011 | By Edward Tabor, MD

New products for cancer indications are often approved by the US Food and Drug Administration (FDA) based on fewer and smaller clinical studies containing a smaller percentage of US patients than treatments for other diseases. For most products used to treat other diseases, FDA usually requires that New Drug Applications (NDAs) have at least two controlled clinical trials.

 

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