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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Drug Approval
Drug Development
Hepatitis B -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Digital Technology
Drug Approval
Investigational New Drug Application
Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Author(s):
- White, Robert S., author
- Publication:
- [Toronto, Ontario] : Thomson Reuters, 23-December-2019
- Subject(s):
- Drug Approval
Drug Therapy
Government Regulation
Orphan Drug Production
Rare Diseases -- drug therapy
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
- Subject(s):
- Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, September 20, 2019
- Subject(s):
- Drug Approval
Therapeutic Equivalency
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
- Subject(s):
- Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
- 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.