GMP News - Blood / Biologics and ATMP

Related to the current issues with the ZIKA virus, the FDA published a new guideline about Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.

The CAT monthly report of the January meeting 2016 provides you with information about statistical data, classification of ATMP, scientific advice and more on ATMP. Read more about application procedures, guidelines and related documents on advanced therapies.

FDA reacts to the Zika Virus hype with a new guidance document: " Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus" by blood and blood components.

As the latest in a series of guidances addressing the risk of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD)1 transmission by blood and blood products, the FDA published the "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products".

Amongst FDA's agency-wide annual Guidance Agenda, the CBER announced an overview about guidance documents they are planning to publish during calendar year 2016. Find out more about the CBER plans.

The FDA adopted and published the Guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Read more about these FDA recommendations.

In October, the FDA published recommendations on microbial vectors for the field of gene therapy. Read more about the guide draft "Recommendations for Microbial Vectors used for Gene Therapy".