FDA Outlook: Guidance Documents CBER is Planning to Publish in 2015

On 24 January, the FDA published a "Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2015". This document contains a list of guidance topics CBER is considering for development during this year. This means the development of new guidance documents as well as updates of existing guidances as well as finalizing draft documents.

Following is an overview about the announced guidance documents.

CATEGORY – 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  • Draft Guidance for Industry: Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus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  • Draft Guidance for Industry: Revised Recommendations for Donor Deferral to Reduce the Risk of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products
  • Draft Guidance for Industry: Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture
  • Draft Guidance for Industry: Recommendations to Reduce the Risk of Transmission-transmitted Chikungunya Virus (CHIKV)

CATEGORY – 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  • Draft Guidance for Industry: Homologous Use of Human Cells, Tissues, and Cellular and Tissue Based Products
  • Draft Guidance for Industry: Recommendations for Microbial Vectors Used for Gene Therapy
  • Draft Guidance for Industry: Manufacturer Investigation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Adverse Reaction

CATEGORY – Other:

  • Final Guidance for Industry: Electronic Submission of Lot Distribution Reports

For further details see the complete guidance agenda.

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