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- Publication:
- Washington, D.C. : U.S. Government Accountability Office, January 2017
- Subject(s):
- Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
Drug Resistance, Bacterial
Guidelines as Topic
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
- Subject(s):
- Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
- Subject(s):
- Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
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, May 2019
- Subject(s):
- Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Author(s):
- White, Robert S, author
- Publication:
- [Toronto, Ontario] : Thomson Reuters, 20-December-2021
- Subject(s):
- Drug Approval
Drug Therapy
Drugs, Investigational
Government Regulation
Illicit Drugs
United States
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
- Subject(s):
- Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
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, 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.
- Publication:
- Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
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, July 2017
- Subject(s):
- Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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, February 2022
- Subject(s):
- Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration