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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 Devices and Radiological Health, December 16, 2019
- Subject(s):
- Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
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 Devices and Radiological Health, March 12, 2020
- Subject(s):
- Device Approval
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 Biologics Evaluation and Research, December 16, 2019
- Subject(s):
- Device Approval -- standards
Checklist
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, September 25, 2020
- Subject(s):
- Accreditation
Equipment and Supplies
Materials Testing
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 2018
- Subject(s):
- Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
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 Devices and Radiological Health, October 2, 2017
- Subject(s):
- Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.