CBER Guidance Agenda - Scheduled activities for 2015

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

On 1 July, the US FDA CBER published a list of guidance topics which should be developed during the calendar year 2015.The list includes topics that currently have no guidance associated to them, topics where updated guidances may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following the review of public comments. The following topics were included:

CATEGORY – Blood and Blood Components:

• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry (published)
• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Final Guidance for Industry
• Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry
• Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry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; Final Guidance for Industry
•  Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry
• Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability
• 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 Industry2

CATEGORY – Cellular, Tissue, and Gene Therapy:

• Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Final Guidance for Industry (published)
• Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral Microbial Products; Final 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; Draft Guidance for Industry (published)
• Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry3
• Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry
• Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema Pallidum (Syphilis); Final Guidance for Industry
• Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Final Guidance for Industry
• Use of Nucleic Acid Tests to Reduce Transmission of West Nile Virus from Donors of HCT/Ps; Final Guidance for Industry

CATEGORY – Other:

• Electronic Submission of Lot Distribution Reports; Final Guidance for Industry (published)

For more information see "Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2015"