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

| 01 July 2011 |  By 

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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