Update: CBER Announces Planned Guidance for 2017
Posted 18 January 2017 | By
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).
|Planned CBER Guidances in 2017|
|Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion||Blood and Blood Components||Revised Draft|
|Implementation of Pathogen-Reduction Measures to Reduce the risks of Transfusion-Transmissible Infections in Transfused Platelets and Plasma||Blood and Blood Components||Draft|
|Revised Preventative Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products||Blood and Blood Components||Draft|
|Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271||Tissues and Advanced Therapies||Final|
|Standards Development and their Use in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research||Other||Draft|
|Chemistry, Manufacturing and Controls Changes to an Approved Application: Biological Products||Other||Draft|
|Newly Added (3 July 2017)|
|Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components||Blood and Blood Components||Final|
|Requalification of Donors Previously Deferred for a history of Viral Hepatitis after their 11th Birthday||Blood and Blood Components||Final|
|An Acceptable Circular of Information for the Use of Human Blood and Blood Components||Blood and Blood Components||Final|
|Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, product Disposition, and Donor Deferral and Reentry||Blood and Blood Components||Final|
|Devices Used in the Recovery, Isolation, or Delivery of Regenerative Medicine Advanced Therapies||Tissues and Advanced Therapies||Draft|