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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
- Subject(s):
- Drugs, Generic -- standards
Investigational New Drug Application
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 Drug Evaluation and Research, August 2017
- Subject(s):
- Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
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, 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 Biologics Evaluation and Research, October 2023
- Subject(s):
- Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States
- Publication:
- Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
- Subject(s):
- Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
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, October 2022
- Subject(s):
- Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
- Subject(s):
- Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Subject(s):
- Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
- Subject(s):
- Antibodies, Monoclonal
COVID-19 Drug Treatment
Drug Approval
Drug Industry
Government Regulation
Legislation, Drug
SARS-CoV-2
United States