CDER Patient-Focused Drug Development  FDA Issues Draft Guidance on Patient Focused Drug Development Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments."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 For information on the draft guidance and how to submit comments, please click here. Upcoming Public Meetings FDA is announcing a series of two public meetings entitled - Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask
- Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis
Meeting #1: June 30th: 11am-1pm Meeting #2: July 25th: 11am-1pm Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Who to Ask and How to Ask This meeting is the first in a series of two public meetings. Topics for Discussion at Meeting #1 (June 30, 2022) Speakers and participants will discuss a range of issues and best practices related to collecting patient input, selecting data collection methods, and developing sampling plans and strategies. External stakeholders will present examples of how they have used the guidance documents as tool to inform their collection of patient data. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents For more information, and to register for Meeting #1, please click here. Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis This meeting is the second in a series of two public meetings. Topics for Discussion at Meeting #2 (July 25, 2022) Speakers and participants will discuss a range of issues data collection and analysis, focusing on lessons learned and on areas identified as particularly challenging for stakeholders. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents For more information, and to register for Meeting #2, please click here. Condition-Specific Meeting Reports and Other Information Related to Patients' Experience Webpage FDA recently published a new webpage titled "Condition-Specific Meeting Reports and Other Information Related to Patients' Experience." This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful. This webpage hosts an alphabetical listing of condition-specific meeting reports and other information related to patients' experience. These meetings include FDA-led Patient-Focused Drug Development (PFDD) meetings, Externally-led PFDD meetings, and Patient Listening Sessions. Other information includes proposed draft guidance relating to patient experience data, natural history studies, or other condition-specific background on condition and discussion of unmet medical need. For more information, and to access the webpage, please click here. | 
No comments:
Post a Comment