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- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
- Subject(s):
- Blood Donors
Chagas Disease -- blood
Chagas Disease -- transmission
Disease Transmission, Infectious -- prevention & control
Donor Selection
Serologic Tests
Trypanosoma cruzi
Chagas Disease -- prevention & control
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017
- Subject(s):
- Equipment and Supplies -- standards
Reproducibility of Results
Software -- standards
International Cooperation
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, December 2017
- Subject(s):
- Advertising as Topic -- standards
Prescription Drugs -- standards
Product Labeling -- standards
Mass Media
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, December 2017
- Subject(s):
- Antibacterial Agents
Antifungal Agents
Drug Labeling -- standards
Investigational New Drug Application
Microbial Sensitivity Tests
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, December 2017
- Subject(s):
- Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
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, December 2017
- Subject(s):
- Communication
Drug Industry
Investigational New Drug Application
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 2017
- Subject(s):
- Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
- Subject(s):
- Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- Washington, D.C. : U.S. Government Accountability Office, May 2017
- Subject(s):
- Dietary Supplements
Drug and Narcotic Control
Government Regulation
Marketing of Health Services
Memory -- drug effects
Memory Disorders -- drug therapy
Advertising as Topic
Commerce
Internet
Humans
United States
United States. Federal Trade Commission.
United States. Food and Drug Administration.
- Publication:
- Washington, D.C. : U.S. Government Accountability Office, May 2017
- Subject(s):
- Drugs, Generic -- economics
Drugs, Investigational -- economics
Investigational New Drug Application -- economics
Drug Approval -- economics
Humans
United States
United States. Food and Drug Administration.