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BIO Comments on FDA Guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments

December 14, 2018

BIO submitted comments to the Food and Drug Administration (FDA) following the public meeting, Patient-Focused Drug Development (PFDD) Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments.

BIO commends the FDA for working to ensure patient experiences are more systematically collected and used to inform the development and review of new therapies.

BIO strongly believes that, in order to truly support patient-focused drug development, patient experience data should be considered for use throughout the drug development and review lifecycle. Appropriate fit-for-purpose tools for collecting patient experience data have the potential to inform protocol design, endpoint development, benefit-risk assessments, and labeling, among other aspects of drug development and assessment. To encourage stakeholders to collect fit-for-purpose patient experience data, we request the FDA more clearly indicate the breadth of regulatory decisions for which they will consider different types of patient experience data.

BIO makes suggestions for how FDA can improve the guidance documents and FDA website, External Resources or Information Related to Patient Experiences. In addition, BIO requests FDA keep the scope of new PFDD guidance documents broadly applicable and flexible.

Download Full Comments Below
BIO LETTER Patient Focused Drug Development Guidance Methods To Identify What Is Important To Patients FDA–2018-N-2455
BIO LETTER_Patient Focused Drug Development Guidance_Methods to Identify What Is Important to Patients_FDA–2018-N-2455
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