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Start Over Subjects Genetic Therapy ✖Remove constraint Subjects: Genetic Therapy Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration.

1. Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

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.

3. Testing of retroviral vector-based human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up

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.

5. Human gene therapy for hemophilia

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.