FDA solidifies its advice on dose optimization for oncology products

By Rachel Coe, MSC

Just over a year after it released the draft guidance, the FDA has finalized its guidance on dose optimization for oncology products. In this analysis, AgencyIQ has combed through the newly released final guidance document to tease out what’s new and what’s the same. We will discuss the context and implications of some of the changes in an upcoming second analysis.

For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology.

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