NCI BRB Regulatory Reference Links

Below is a list of links to resources containing finer details of the requirements for producing a biological for the clinic:

• US Code of Federal Regulations – Food and Drugs Chapter 21 (21CFR) link (http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199821)
• US Food and Drug Administration (FDA) website (http://www.fda.gov/default.htm)
• FDA Center for Drug Evaluation and Research (CDER) (http://www.fda.gov/cder/index.html)
• FDA Center for Biologics Evaluation and Research (CBER) website (http://www.fda.gov/cber/index.html)
• Regulatory Affairs Professional Society website (http://www.raps.org/)
• The International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use website (http://www.ich.org/)

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