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Comments on FDA Patient-Focused Drug Development

Dear ISPOR colleagues,

Earlier this year the FDA indicated that they would be circulating 4 draft guidances related to Patient-Focused Drug Development. With your help, ISPOR responded to first one in October 2018. The second one, focusing on “Approaches to identify what is most important to patients with respect to their experience as it relates to burden of disease and burden of treatment,” is now available for comment. Their announcement, the draft guidance, and related documents can be found here.

To help ISPOR formulate its response, we would welcome your comments on the guidance. Please note the specific line numbers in your comments whenever appropriate.

I. Introduction (lines 14 - 73)
II. Methods to Identify and Understand What is Important to Patients (lines 76 - 116)
III. Qualitative Research Methods (lines 121 - 243)
IV. Quantitative Research Methods lines (248 - 366)
V. Mixed Methods (lines 367 - 413)
VI. Specific Populations and (Children, Cognitively Impaired, Rare Diseases) and Culturally Diverse Populations (lines 414 - 469)
VII. Considerations for Use of Social Media (lines 471 - 496)
Appendices (lines  593 - 1163)