To include your compound in the COVID-19 Resource Center, submit it here.

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

Read the full 541 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE