In June of 2022, the U.S. Food and Drug Administration (FDA) released new draft guidance for industry, FDA staff, and other stakeholders.
When finalized, the draft guidance, entitled Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, will represent the current thinking of CDER, CBER, and CDRH on how stakeholders can collect and submit patient experience data to be used for the development of drugs, biologics, and medical devices as well as for regulatory decision-making.
What is the purpose of the draft guidance?
It is intended to help sponsors implement high quality measurement of patient health. Benefits of quality measurements include:
- Evaluation of what matters to patients
- Clarity about what was measured
- Evaluation of the effectiveness, tolerability, and safety of treatments
- Avoidance of misleading claims
- Data support support for regulatory decision-making in a variety of contexts
See the Federal Register Notice for more information on the guidance and to submit a formal comment. The comment period that ends on September 28, 2022.
