CBER's Guidance Agenda: Guidance Documents should be published during calendar year 2016

Recommendation

7/8 May 2024

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

On 14 January, the Center for Biologics Evaluation and Research (CBER) of  the Food and Drug Administration published their annual outlook for possible guidance developments during Calendar Year 2016. Typically the list reflects the guidance documents or topics without a current guidance. The list includes 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.

Following the announced topics:

Blood and 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• Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry
• Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry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Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry (Revised Draft1)
• 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 (published)
• Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry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the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion”; Draft Guidance for Industry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and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance for Industry (published)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Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry (published)

 Other:

• 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

For more details please take a look at "Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016"