PANDEMIC SPURRED NEW R&D APPROACHES FROM PHARMA, FDA IN 2022

ABSTRACT

The article offers information on the ongoing surge in Research and Development for cell and gene therapies prompted a reorganization and expansion of Food and Drug Administration (FDA) offices overseeing these products and efforts to clarify and update regulatory policies in the area. It discusses that FDA recognized the challenges in overseeing these developments as it moved to revive field inspection operations for manufacturing facilities and bioresearch operations.