7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products of unknown safety and efficacy. 

By clarifying its position on the handling and therapeutic use of cells, the agency has sent a clear signal that it intends to regulate a broad swath of highly manipulated cellular materials as biologic drugs. 

This is a welcome development, and complementary action taken at the state level and by professional societies would further promote the interests of patients.

Read New England Journal of Medicine perspective