BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).