CBER DIRECTOR PETER MARKS SAYS FDA PLANS TO EXPLORE WHETHER THERE IS AN INTERMEDIATE PATHWAY BETWEEN TISSUE REGULATIONS AND A FULL BLA FOR CERTAIN CELLULAR PRODUCTS. Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, Getty images
https://pink.pharmaintelligence.informa.com/PS146208/US-FDA-To-Explore-New-Regulatory-Pathways-For-Some-Cellular-Products