BIO Submits Comments on Patient Preference Information
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”
BIO welcomes this guidance and applauds the Center for Devices and Radiological Health (CDRH) for a thoughtful and well-written Draft Guidance. BIO strongly agrees that “...patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices.” Patient preferences provide invaluable input into clinical development programs that can improve both the efficiency and effectiveness of clinical research, as well as address the issues that are most important to patients.
