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  6. Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
  1. Lot Release

Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic

March 19, 2020

In response to the ongoing COVID-19 pandemic, the Center for Biologics Evaluation and Research (CBER) intends to pause certain lot release activities and will not be receiving biological product samples or protocols in physical form (paper or CD-ROM) at the FDA White Oak campus in Silver Spring, Maryland beginning March 23, 2020, until further notice. CBER’s Office of Compliance and Biologics Quality (OCBQ) has provided manufacturers with logistical information to assist with continuation of the lot release process during this period. CBER wants to emphasize that the lot release process for licensed biological products will continue during this pause in receipt of samples and protocols in physical form.

When we resume normal operations, we will send an update to manufacturers and will post information on this webpage.

During this pause in certain lot release activities, we will continue to prepare needed reagents for the upcoming 2020/2021 Influenza season.

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