federal_register: 2012-31043
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-31043 | Public Workshop on Minimal Residual Disease; Public Workshop | Notice | The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). Our objective is for the workshop to provide a venue for an in-depth discussion of potential endpoints for trials intended to support the approval of new drugs or biologics for treatment of AML. Participants in the workshop will examine if any currently used biomarker can be used as a surrogate endpoint, identify the preferred technology platform and performance characteristics for the assay of the biomarker, discuss any issues regarding ongoing deficiencies in methodological standardization for the biomarker, and determine the need for additional FDA-approved in-vitro diagnostics for AML drug development. The primary focus will be on the biomarkers that are or will soon be ready for incorporation into clinical trials, and the technical and regulatory challenges for use of these markers. | 2012-12-26 | 2012 | 12 | https://www.federalregister.gov/documents/2012/12/26/2012-31043/public-workshop-on-minimal-residual-disease-public-workshop | https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/2012-31043.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection... |