FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood.
FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While the documents do not carry the force of law, they are nevertheless hugely influential within the life sciences industry.
CBER's 23 January 2015 release of its so-called "Guidance Agenda" contains a list of 11 guidance documents the Center says it is planning to release in 2015. The documents include Draft Guidance for Industry: Revised Recommendations for Donor Deferral to Reduce the Risk of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products, which is set to allow gay men to donate blood so long as they have been abstinent for the last year.
The list also contains plans to release guidance on how blood banks should treat patients who might have been exposed to the Ebola virus or the Chikungunya virus, as well as a long-sought guidance on the homologous use of human cell and tissue products.
While FDA often releases many of the guidances on its agenda lists, it rarely publishes all of them.
Guidance Documents Planned by CBER in 2015
| BLOOD AND BLOOD COMPONENTS: |
|---|
| Draft Guidance for Industry: Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus |
| Final Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation |
| Draft Guidance for Industry: Revised Recommendations for Donor Deferral to Reduce the Risk of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products |
| Draft Guidance for Industry: Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture |
| Draft Guidance for Industry: Recommendations to Reduce the Risk of Transmission-transmitted Chikungunya Virus (CHIKV) |
| CELLULAR, TISSUE, AND GENE THERAPY: |
| Final Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products |
| Final Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and related Recombinant Viral or Microbial Products |
| Draft Guidance for Industry: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products |
| Draft Guidance for Industry: Recommendations for Microbial Vectors Used for Gene Therapy |
| Draft Guidance for Industry: Manufacturer Investigation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Adverse Reactions |
| OTHER: |
| Final Guidance for Industry: Electronic Submission of Lot Distribution Reports |