How excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companies

Summary

The article argues that excessive FDA manufacturing requirements are crippling cell and gene therapy companies, using Grace Therapeutics as a case study. Grace may shut down after the FDA demanded a costly second manufacturing run before allowing a new drug application. The author contends this is a systemic problem where overly burdensome manufacturing regulations — a "boring" but critical bottleneck — are killing promising therapies before they reach patients, particularly for ultra-rare diseases where small patient populations make high compliance costs unsustainable.

Source

bskyHow excessive FDA manufacturing requirements are bottlenecking cell and gene therapy companieswritingruxandrabio.com