FDA to bulk up cell and gene therapy staff, growing with the field

Dive Brief:

• Aiming to keep pace with the acceleration of cell and gene therapy research, the Food and Drug Administration plans to expand its clinical review staff, release a series of wide-ranging guidance documents and crack down on bad actors, two agency leaders said in a statement released Tuesday.
• FDA Commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research, said in a joint statement they anticipate more than 200 Investigational New Drug applications per year by 2020 for cell and gene therapeutic candidates, adding to a current total of more than 800 such filings. That will help lead to, they predict, 10 to 20 approvals each year for these treatments by 2025.
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