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Regulatory News | 18 January 2017 | By Michael Mezher
Editor's note: This article was updated 3 July 2017 to reflect the addition of five guidances to CBER's planned guidance agenda for 2017. The table below has been edited to reflect the newly added guidances.
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research on Wednesday announced the guidance documents it plans to publish in 2017.
While CBER says the list includes the guidances it plans to publish this year, the center notes that it is not bound by the list, and that it may work on additional guidance other than what is listed.
In total, CBER says it plans to either finalize or draft six additional guidances this year, on top of two guidances issued earlier in January ( Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus and Labeling of Red Blood Cell Units with Historical Antigen Typical Results).