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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Subject(s):
- Biological Products
Drug Approval
Licensure
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 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, September 2020
- Subject(s):
- Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
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:
- 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, 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 : 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, March 2020
- Subject(s):
- Drug Approval
Drugs, Generic
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 Biologics Evaluation and Research, December 2019
- Subject(s):
- Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
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 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.