Earlier this month, FDA’s Center for Biologics Evaluation and Research (CBER) published its annual guidance agenda. CBER’s list is published in addition to the FDA’s agency-wide Annual Guidance Agenda (in which CBER’s list is included), which outlines the guidance documents the Agency plans to publish during the 2016 calendar year.
The Center’s 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.” Broken down by category, CBER’s 2016 guidance agenda includes the following topics:
Blood & Blood Components
- Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry
- Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry (Revised draft – initial draft issued in December 2014)
- Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry (on January 14, 2016, CBER finalized the June 2012 draft guidance)
- Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry
- 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the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion”; Draft Guidance for Industry
Cellular, Tissue, and Gene Therapy
- 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and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance for Industry (published)
- Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Final Guidance for Industry
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry (published by CBER on January 8, 2016.)
- Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry
- Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Final Guidance for Industry
In its announcement, CBER states that, although it intends to develop the guidance documents on the topics listed above, “the Center is neither bound by this list of topics, nor required to issue every guidance document on this list.” In addition, the Center also states that it is not precluded from developing guidance documents on topics which are not included within the list.