ABSTRACT

The Web page reproduced here is maintained by FDA's Center for Biologics Evaluation and Research. It lists all the guidances produced by CBER, organized in reverse chronological order, with the most recently posted guidances appearing first. Each of the guidance documents listed is a link to the full-text version of that guidance document. To make sure you have access to the most recently available guidances, you should visit the Web page at https://www.fda.gov/cber/guidelines.htm.