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1. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation -- standards
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Betibeglogene autotemcel for beta thalassemia: effectiveness and value : final evidence report

Author(s):
Beaudoin, Francesca L., author
Richardson, Marina, author
Synnott, Patricia G., author
Lancaster, Victoria, author
Fluetsch, Noemi, author
Herce-Hagiwara, Belén, author
Campbell, Jon D., author
Pearson, Steven D., author
Rind, David M., author
Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, July 19, 2022
Subject(s):
beta-Thalassemia -- therapy
Biological Products -- therapeutic use
Genetic Therapy
United States

8. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

Author(s):
Purvis, Leigh, author
Publication:
Washington, D.C. : AARP Public Policy Institute, September 2014
Subject(s):
Biological Products -- economics
Biological Products -- therapeutic use
Biosimilar Pharmaceuticals -- economics
Biosimilar Pharmaceuticals -- therapeutic use
Drug Costs
Drug Substitution
Legislation, Drug
Drugs, Generic -- economics
Federal Government
State Government
Humans
United States
United States. Food and Drug Administration.
United States.

9. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators

Publication:
[Silver Spring, MD] : Oncology Center of Excellence, June 2020
Subject(s):
Biological Products -- therapeutic use
COVID-19 -- drug therapy
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.