CBER Pauses Lot Release Activities Due to Coronavirus

Regulatory NewsRegulatory News | 20 March 2020 |  By 

As the US Food and Drug Administration (FDA) re-gears to respond to the coronavirus disease (COVID-19) pandemic, the agency’s Center for Biologics Evaluation and Research (CBER) says it will “significantly scale back” lot release activities beginning next Monday.
 
In a letter to biological product manufacturers dated Tuesday, CBER’s Office of Compliance and Biologics Quality (OCBQ) advises that it will no longer accept biological product samples or lot release protocols in physical form (paper or CD-ROM) at the agency’s headquarters in Silver Spring, MD until further notice.
 
Despite the pause in other lot release activities, CBER says it will continue to prepare reagents for the 2020/2021 influenza season.
 
The letter also provides logistical instructions for manufacturers to assist them in continuing their lot release processes in the interim and stresses that “electronic lot release protocols submitted through the FDA will not be impacted.”
 
Companies are instructed to convert their CD-based lot release protocols to PDF format and submit them to the agency via email, with specific instructions for subject line and filename convention.
 
The letter also highlights FDA’s reliance on some outdated technology.
 
“Normally the final release notification is faxed with a follow-up copy mailed to the manufacturer. Under this temporary process, we will not be able to fax the final release notices, and there will be a delay in sending the mailed copy,” FDA writes, noting that companies should provide an email address for their point of contact.
 
Earlier this week, federal agencies, including FDA, were instructed to maximize telework, putting fax machines at the office out of reach for many employees.
 
FDA

 

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