ARTICLE | Politics & Policy

FDA planning class-wide cancer companion diagnostic guidance

November 20, 2018 10:28 PM UTC

FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury.

Class-wide labeling would give physicians more flexibility to prescribe drugs and reduce the likelihood of patients having to undergo multiple biopsies to determine whether specific drugs could be of benefit, Gottlieb said...