BIO Submits Comments on Patient Engagement during Medical Product Development
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on potential strategies to enhance patient participation in drug and biologic development discussions.</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on potential strategies to enhance patient participation in drug and biologic development discussions. The future of drug development will require active collaboration and cooperation between FDA, drug Sponsors, and, most importantly, patients to better understand patient perspectives and views on study designs, meaningful clinical outcomes, and benefit/risk determinations. Methods for soliciting the views of patients, as well as their caregivers and healthcare providers, should be further evolved into data-driven mechanisms for conveying the patient perspective and preferences at all stages of the drug development process.
