Regulatory concerns in the development of biologic-biomaterial combinations

24Citations
Citations of this article
9Readers
Mendeley users who have this article in their library.
Get full text

Abstract

Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of 'Points to Consider' documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

Cite

CITATION STYLE

APA

Chapekar, M. S. (1996). Regulatory concerns in the development of biologic-biomaterial combinations. Journal of Biomedical Materials Research, 33(3), 199–203. https://doi.org/10.1002/(SICI)1097-4636(199623)33:3<199::AID-JBM10>3.0.CO;2-C

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free