Amylyx picks up ALS drug approval in Canada after FDA asks for more time to review the data – Endpoints News

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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