FDA promising carrots and sticks for gene, cell therapy developers

Looking past the shutdown, FDA Tuesday outlined policies it is taking to ramp up regulatory support for cell and gene therapy products. It is also threatening to crack down on investigators and clinicians who refuse to submit cell therapies to premarket review.

The agency plans to add about 50 clinical reviewers dedicated to oversight of cell and gene therapies, about a 50% increase over current levels. It did not indicate a time frame for bringing the new staff on board. ...