Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biomarkers Clinical Trials as Topic Drug Approval Drug Development Drugs, Investigational Hematologic Neoplasms -- drug therapy Investigational New Drug Application Neoplasm, Residual Endpoint Determination Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy Leukemia, Myeloid, Acute -- drug therapy Leukemia, Promyelocytic, Acute -- drug therapy Multiple Myeloma -- drug therapy Patient Selection Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy Prognosis Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (18 pages)).
- NLM Unique ID:
- 101760029 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101760029