FDA Issues Draft Guidance on Patient Focused Drug Development - Drug Information Update

FDA Issues Draft Guidance on Patient Focused Drug Development

If your email program has trouble displaying this email, view it as a web page. FDA Issues Draft Guidance on Patient Focused Drug Development Today, the U.S. Food and Drug Administration issued a draft guidance, "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments."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. For information on the draft guidance and how to submit comments, please see the Federal Register Notice. This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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