The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).
On 29 June, the FDA published a draft guidance titled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. It’s the third in a series of four guidances the agency is developing to further field of patient-focused drug development (PFDD); the final guidance will focus on incorporating COAs into endpoints for regulatory decision-making. (RELATED: FDA’s first patient-focused drug development guidance now final, Regulatory Focus 17 June 2020; PFDD: FDA finalizes guidance on identifying what’s important to patients, Regulatory Focus 28 February 2022)…
