|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Issues Draft Guidance on Patient Focused Drug Development
Today, the U.S. Food and Drug Administration issued a draft guidance, "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments." This guidance (Guidance 3) is the third in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. When final, this guidance will represent the current thinking of FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health on this topic.
When final, the purpose of this guidance is to help sponsors identify or develop fit-for-purpose COA measures of patients' health that are appropriate for use in a medical product development program. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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