Bloomberg Law
June 12, 2019, 1:30 PM

Slow Response by Stem Cell Developers Prompts New FDA Program

Jeannie Baumann
Jeannie Baumann

A slow response from developers of stem cells and other treatments to repair diseased or damaged cells and tissues has prompted the FDA to tweak its framework for regulating these therapies.

The Food and Drug Administration issued a regulatory framework for regenerative medicine in November 2017 that aimed to spur innovative therapies that engineer cells and tissues while cracking down on clinics charging patients for unproven and potentially dangerous stem cell therapies.

The FDA regulates a wide range of cell and tissue products, but not everything requires a pre-market review to authorize clinical testing of an experimental product with an ...