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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, May 2021
- Subject(s):
- Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
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, 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, November 2020
- Subject(s):
- Drug Approval
Prescription Drugs
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, October 2023
- Subject(s):
- Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States
- 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