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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
- Subject(s):
- Risk Evaluation and Mitigation -- standards
Drug Approval
Drug Labeling
Safety
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 2019
- Subject(s):
- Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
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 : Food and Drug Administration, Oncology Center of Excellence, October 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
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:
- Washington, DC : United States Government Accountability Office, November 2018
- Subject(s):
- Drug Approval
Orphan Drug Production
United States
United States. Food and Drug Administration.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2019
- Subject(s):
- Drug Approval
Insurance, Health, Reimbursement -- economics
Insurance, Health, Reimbursement -- statistics & numerical data
Medicaid -- economics
Medicaid -- statistics & numerical data
Economics, Pharmaceutical
Fraud -- prevention & control
Prescription Drugs -- economics
Humans
United States
United States. Food and Drug Administration.
- 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:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
- Subject(s):
- Drug Approval
Legislation, Drug
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 Biologics Evaluation and Research, October 2023
- Subject(s):
- Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States
