FDAsafety guidance83% confidence
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (prostate cancer) as Janssen.
Regulatory Analysis
This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.
Supporting Context
- Therapeutic area
- Oncology · Prostate Cancer
- Sub-indication
- Prostate Cancer
Related signal: Janssen's Apalutamide Study Targets mCRPC in Chinese Patients