Amgen and Novartis want the FDA to clarify which compounds would require an assessment of suicidal thoughts and behaviors under draft guidance the agency issued in August. The FDA’s guidance, Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials, directs drugmakers to consider assessments for suicidal ideation and behaviors in drugs that “appear to have CNS effects.” In commenting on the draft, Amgen requested the FDA be more specific in what it means by “CNS effects.”
Washington Drug Letter