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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

321. 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.

323. 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.

325. 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.

327. Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

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.

330. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

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.