FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies
"The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics ? tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency?s policy for reviewing a companion diagnostic and the corresponding therapy."
"Identifies instances where the FDA may approve a targeted medicine in the absence of a cleared or approved companion diagnostic. In cases where the therapy is intended to treat a serious or life-threatening disease or condition for which there is no available or satisfactory treatment and when the potential benefits outweigh the risks of not having a cleared or approved companion diagnostic, the therapy could be approved first while the companion diagnostic may be approved or cleared later through the appropriate device submission process."
