US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.”
The draft guidance document (Guidance 4) is part of a series of four documents aimed at collecting and submitting patient experience data and other relevant information for the development and regulation of medicinal products
The purpose is to:
- improve the inclusion of clinical outcome assessment in robust endpoints for regulatory decision-making
- suggest methodologies, standards, and technologies that can be used to collect, store, and analyze patient perspective data
- provide resources to help with the submission of patient experience data.
Sponsors and other stakeholders are encouraged to submit either electronic or written comments on the draft guidance by July 5, 2023.
Need to know more about Medical Devices regulation changes? Get in touch with RegASK’s experts.