 | In a letter to the Food and Drug Administration (FDA), PIPC offered comments on the FDA’s guidance on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints for Regulatory Decision-Making.” |
The letter compliments the FDA’s efforts to provide stakeholders with a standardized process for collecting and submitting patient experience data and other relevant information from patients and caregivers and to use that information in the regulatory decision-making process.
“We applaud the FDA’s attention to the concepts of patient-centeredness and patient engagement in the conduct of research and the approval process,” wrote PIPC Chair Tony Coelho. “PIPC looks forward to continuing its efforts to bring the voices of patients and people with disabilities to the discussion of how to advance patient-centered principles throughout an evolving health care system.”
“We applaud the FDA’s attention to the concepts of patient-centeredness and patient engagement in the conduct of research and the approval process,” wrote PIPC Chair Tony Coelho. “PIPC looks forward to continuing its efforts to bring the voices of patients and people with disabilities to the discussion of how to advance patient-centered principles throughout an evolving health care system.”
| pipc_fda_pfdd_final.pdf |
