Placeholder Banner

BIO Comments on Patient-Focused Drug Development Guidance: 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 on the Food and Drug Administration’s (FDA) open docket, Patient-Focused Drug Development 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 in the development and review of new therapies. In particular, BIO appreciates the work to develop guidance documents and discussion guides prior to public meetings.

To truly support patient-focused drug development, BIO believes patient experience data should be considered for use throughout the development and review lifecycle. Appropriate “fit-for-purpose” tools for collecting patient experience data have the potential to inform many aspects of drug development and assessment. To encourage stakeholders to collect fit-for-purpose patient experience data, BIO requests FDA publicly and clearly explain how and when they will use patient experience data in different drug development and regulatory decisions. In addition, BIO provides general comments and line edits as well as responses to questions posed by the FDA in the open docket.

Download Full Comments Below
BIO LETTER Patient Focused Drug Development Guidance Methods To Identify What Is Important To Patients FDA–2018-N-2455 0
Read full comment letter below
Discover More
Innovative breakthroughs can secure our nation’s food supply by reducing greenhouse gas emissions throughout agricultural supply chains; strengthening producers’ resiliency to climate change while increasing production; and tackling hunger and…
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…