FDA's Companion Dx Guidance Slated for Early 2011; Codevelopment Guidance out Later, Gutierrez Says
December 08, 2010
FDA's Companion Dx Guidance Slated for Early 2011; Codevelopment Guidance out Later, Gutierrez Says
Until now, the FDA has not publicly stated that it intends to issue two separate guidances on Rx/Dx development: one focusing solely on advancing companion tests, and another document on how to gain regulatory approval for a drug and test simultaneously.
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