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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
- Subject(s):
- Dosage Forms -- standards
Drug Approval
Drug Development
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 Products -- standards
Drug Approval
Drug Development
Nanostructures
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, 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 Drug Evaluation and Research, February 2019
- Subject(s):
- Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
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, March 2019
- Subject(s):
- Drug Development
HIV Infections -- prevention & control
Pre-Exposure Prophylaxis
Adolescent
Child
Clinical Trials as Topic
HIV Infections -- drug therapy
HIV-1
Infant
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 : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Urinary Tract Infections -- drug therapy
Pharmacokinetics
Research Design
Safety
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, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
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, August 2019
- Subject(s):
- Candidiasis, Vulvovaginal -- drug therapy
Clinical Trials as Topic -- standards
Drug Development
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
