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- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
- Subject(s):
- Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
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, January 2020
- Subject(s):
- Clinical Trials as Topic
Genetic Therapy
Drug Evaluation, Preclinical
Retinal Diseases -- therapy
Investigational New Drug Application
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, January 2020
- Subject(s):
- Drug Contamination
Genetic Therapy
Genetic Vectors
Retroviridae
Virus Replication
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, January 2020
- Subject(s):
- Drug Development
Genetic Therapy
Rare Diseases -- therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
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, January 2020
- Subject(s):
- Genetic Therapy
Hemophilia A -- drug therapy
Hemophilia B -- drug therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
Factor VIII -- therapeutic use
Factor IX -- therapeutic use
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, January 2020
- Subject(s):
- Genetic Therapy -- adverse effects
Product Surveillance, Postmarketing
Drug Evaluation, Preclinical
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, February 2020
- Subject(s):
- Blood Transfusion -- standards
HTLV-I Antibodies -- blood
HTLV-II Antibodies -- blood
HTLV-I Infections -- transmission
HTLV-II Infections -- transmission
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, February 13, 2020
- Subject(s):
- Atherectomy -- instrumentation
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, February 2020
- Subject(s):
- Drug Approval
Electronic Data Processing
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, February 26, 2020
- Subject(s):
- Clinical Laboratory Techniques -- standards
Diagnostic Errors
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
