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Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

 
• By Michael Cipriano

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Decorin protein

In anticipating a glut of new investigational new drug (IND) applications for cell and gene therapies in the coming years, the US FDA announced its goal to add 50 additional clinical reviewers to deal with the growing workload.

In a Jan. 15 statement from FDA Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks, the regulators predicted that the agency will be receiving more than 200 INDs per year by 2020

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Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 
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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

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