Gene Therapy Trials to Get New Guidances in 2021, FDA’s Biologics Center Says
The FDA will address trials of new gene therapy treatments in upcoming guidances, according to the agency’s Center for Biologics Evaluation and Research (CBER).
CBER’s 2021 plan also includes issuing guidances on trials of products for neurodegenerative diseases and development of chimeric antigen receptor T-cell (CAR-T) therapies. Also included on the list is a draft guidance on COVID-19 convalescent plasma that the center issued last month. The CBER agenda comes one week after the Center for Drug Evaluation and Research released its 2021 guidance plan (CenterWatch Weekly, Feb. 1).
CBER did not specify when it will issue the guidances.
Read CBER’s guidance agenda here: https://bit.ly/3jgRUl2.