FDA Issues Questions and Answers on Implementing ICH S9 Guidance

Cancer drug sponsors facing challenges in implementing the ICH S9 guidance on nonclinical evaluations of their drugs may find answers in a new ICH guidance released by the FDA.

ICH S9 provides information for drugs intended to treat cancer in patients with late stage or advanced disease, including the type and timing of nonclinical studies.

The new ICH guidance includes 41 questions addressing the scope of ICH S9, studies needed to support nonclinical evaluations, nonclinical data to support clinical trial design and marketing, among other issues.