CBER to in­dus­try: Nor­mal op­er­a­tions will re­sume in 2023

The FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER) has de­vot­ed long hours to the pan­dem­ic, with marathon ses­sions churn­ing out guid­ance doc­u­ments and re­views with­in weeks when those tasks nor­mal­ly take months.

But this Covid-19 work has come at the ex­pense of oth­er ground­break­ing work the cen­ter reg­u­lates, in­clud­ing cell and gene ther­a­pies and oth­er re­gen­er­a­tive med­i­cines.

“As we en­ter cal­en­dar year 2023, we plan to re­sume nor­mal op­er­a­tions,” CBER told spon­sors and oth­er stake­hold­ers in a let­ter dat­ed June 9, which of­fered the cen­ter’s first up­date on its op­er­a­tional plans since April 2020. “For the re­main­der of this cal­en­dar year, CBER will con­tin­ue to pri­or­i­tize re­sources for Covid-19 reg­u­la­to­ry work over non-Covid-19 work, as need­ed, to re­spond to the on­go­ing pub­lic health emer­gency.”

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