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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
- Subject(s):
- Drug Labeling -- standards
Pediatrics
Product Labeling -- standards
Adolescent
Biological Products
Child
Child, Preschool
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, May 2019
- Subject(s):
- Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
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):
- Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
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):
- Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
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, November 2019
- Subject(s):
- Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
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 2023
- Subject(s):
- Biological Products
Drug Compounding
Drug Development
Drug Industry
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Subject(s):
- Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States
- 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 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, November 2023
- Subject(s):
- Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Neoplasms -- drug therapy
United States