Sascha on PDUFA

As important stakeholders in the drug development and approval process, patients provide a unique and valuable perspective when considering the benefits and risks of potential new and innovative medicines.  Patients can identify areas of unmet medical need, provide critical perspective on the impact of a disease and its manifestations, and uniquely inform the development of outcome measures that are meaningful to patients.  A scientific approach to gathering patient input is necessary to realize the shared goal of a patient-centered approach to drug development and regulatory review.  PhRMA believes that advancing the science of patient input should be a collaborative, multi-stakeholder effort.  We must combine the best knowledge and experience to identify ways to improve the efficiency of bringing new medicines to patients in need through an enhanced understanding of the patient perspective on their disease or condition, and unmet medical needs.  A scientific approach to patient-centered drug development would allow for the systematic consideration of the views of patients – their perception of the acceptable balance of known and possible risks and benefits of a potential new medicine in the face of known and possible risks of their disease or condition – when regulators and sponsors are faced with difficult benefit-risk decisions. Further, a robust, scientific understanding of the patient perspective on burden of disease, the symptoms that have the most profound im...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news