CBER Announces Guidance Documents It Plans to Issue in 2017
On January 18, 2017, the FDA’s Center for Biologics Evaluation and Research (CBER) released its 2017 guidance agenda, which outlines the guidance documents that the Center plans to publish throughout the year. According to CBER’s announcement, “the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments.”
The Center states that although it intends to develop guidance documents on these topics, it is not bound by the list or required to issue every guidance included in the list, nor is it “precluded from developing guidance documents on topics not on this list.”
CBER last updated its 2016 guidance agenda in August of last year, so the 2017 agenda includes all guidance documents issued since then.
The list is organized by category and includes the following:
Blood & Blood Components
Guidance Documents CBER is Planning to Issue in 2017:
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Final Guidance for Industry
- Implementation of Pathogen-Reduction Measures to Reduce the Risks of Transfusion-Transmissible Infections in Transfused Platelets and Plasma; Draft Guidance for Industry
- Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Draft Guidance for Industry
Guidance Documents Issued Since the August 2016 Guidance Agenda Update:
- Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry (issued August 2016 – final)
- Amendment to “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion”; Draft Guidance for Industry (issued November 2016)
- Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry (issued January 2017)
- Recommendations for Assessment of Blood Donor Eligibility; Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry (issued January 2017 – final)
Tissues & Advanced Therapies
Guidance Documents CBER is Planning to Issue in 2017:
- 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; Final Guidance for Industry
- Standards Development and their Use in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff
Guidance Documents Issued Since the August 2016 Guidance Agenda Update:
- Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry (issued September 2016 – final)
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (issued September 2016 – final)
- Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissue, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry (issued November 2016 – final)
- Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry (issued December 2016 – final)
Other
Guidance Documents CBER is Planning to Issue in 2017:
- Chemistry, Manufacturing and Controls Changes to an Approved Application: Biological Products; Draft Guidance for Industry
