Biologics Developers Can Use Industry Standards, FDA Says

Biologics sponsors are encouraged to follow established, voluntary standards when developing new products, the FDA said in new draft guidance it issued Dec. 19.

The guidance said the Food and Drug Administration’s Center for Biologics Evaluation and Research welcomes sponsors’ adherence to “voluntary consensus standards” set by industry associations or technical societies.

The FDA said the benefits of using existing standards include minimizing the need for the government to develop its own unique standards and making known what kinds of standards are acceptable to CBER. For CBER-regulated product sponsors, using voluntary standards reduces the need to develop unique methods or ...