Subjects: Biological Products -- therapeutic use - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Biological Products -- therapeutic use ✖ Publication Year 2017 to 2019 ✖

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.