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FDA Biomarker Qualification Program process-with short FDA recap video and slides, plus O&D Director video for biomarker approval watch second youtube video in second headline for recap and third youtube video by O&D biomarker c0-director-more technical 1- FDA CASE STUDY A collaborative effort to qualify a novel biomarker 2-Qualifying a Biomarker through the Biomarker Qualification ProgramWhat is the FDA Biomarker Qualification Program (BQP)?FDA has established the BQP to work with external stakeholders to develop biomarkers for use in drug development. The BQP offers a formal process to guide submitters as they develop biomarkers, and the BQP rigorously evaluates the submitted data for a particular context of use. Making Biomarker Development SuccessfulWhat does the qualification of a biomarker mean?Qualification of a biomarker means that within a stated context of use (COU), the biomarker has been demonstrated to reliably support a specified manner of interpretation and application in drug development. Once qualified, the biomarker information is made publicly available (through an FDA Guidance Document) and the biomarker can be used in multiple drug development programs under its qualified COU. What Does Biomarker Qualification Do (And Not Do)?Are only newly developed biomarkers eligible for qualification?No, FDA will consider qualification of both new and existing biomarkers. Does a biomarker have to be qualified to be used in drug development?No. A biomarker does not have to be qualified to be used in drug development. Biomarker data for any biomarker can be reviewed and the biomarker accepted in the context of a specific candidate drug application; however, any future use of the biomarker in drug development may require a new review by FDA. If a biomarker has previously been used to support claims in drug labeling, does it mean that the biomarker is qualified?No. Only biomarkers that have been reviewed and obtained qualification through the BQP are considered qualified. Biomarkers that have not been formally qualified by the BQP may still be acceptable for use in drug development and could support labeling claims through the FDA Drug Approval Process. Does qualification of a biomarker also qualify the specific test performing the biomarker measurement?No. Biomarkers being considered for qualification are independent of the specific test used to perform the measurement. A biomarker, however, cannot be qualified without a reliable means to measure it. Therefore, the preanalytical considerations and the performance characteristics of the test(s) used to provide the biomarker data will be considered during the qualification review. FDA clearance or approval of a testing device for use in clinical practice does not imply that the biomarker it measures has been demonstrated to have a qualified use in drug development. Additionally, qualification of a biomarker does not automatically imply that a specific test device used in the qualification process for the biomarker has been reviewed by FDA and cleared or approved for use in patient care. Can different assays, tests, or methods be used by drug sponsors when using a qualified biomarker in an IND/NDA/BLA?Yes. Any analytically validated assay, test, or method may be used to measure a qualified biomarker in an IND/NDA/BLA submission, as long as the performance characteristics of the assay, test, or method meet the requirements stated in the qualification guidance document. 3-Biomarker Qualification Program The Biomarker Qualification Program was established to support the Center for Drug Evaluation and Research’s (CDER's) work with external stakeholders to develop biomarkers that aid in the drug development process. Through the FDA’s Biomarker Qualification Program, you may request regulatory qualification of a biomarker for a particular context of use in drug development. Biomarkers can be used in a variety of settings, including basic research, drug development, and clinical practice. The Biomarker Qualification Program focuses on biomarkers used in drug development. Once a biomarker is qualified, it can be used in any drug development program under the context for which it obtained qualification. The Biomarker Qualification Program is one of the Drug Development Tools (DDT) Qualification Programs
created by CDER to provide a framework for development and regulatory
acceptance of scientific tools for use in drug development programs. Why qualify a biomarker through the CDER Biomarker Qualification Program? A qualified biomarker can be used in multiple drug development programs without a need for CDER to reconfirm the suitability of the biomarker’s qualified context of use and has the potential to advance public health by streamlining the drug development paradigm. What is the process to qualify a biomarker?
Submit a biomarker for qualificationCDER will work collaboratively with requestors through the biomarker qualification process, whether for a single biomarker or for a panel of biomarkers. Requestors should contact CDER to start the qualification process once they have all of the following:
Information for biomarker qualification requestors Submission Assistance |
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Msg # | Subject | Author | Recs | Date Posted |
21306 | Re: FDA Biomarker Qualification Program process-with short FDA recap video and slides, plus O&D Director video for biomarker approval | dwdinvesting | 0 | 11/19/2017 1:45:16 AM |