Skip to main content

Regulatory & Access Resources

Browse our regulatory & access resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some important things to keep in mind about the scope of the draft guidance. Importantly, this draft guidance applies only to early-phase clinical trials of CGT products, and the FDA explicitly states...