GMP News - Blood / Biologics and ATMP

17.03.16

ZIKA Virus - Reducing the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products

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.

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17.03.16

EMA Guideline on the clinical evaluation of Factor VIII products published

The EMA published the new Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products with necessary information when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made.

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17.03.16

ATMP - Monthly Report of the CAT January 2016

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.

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17.03.16

FDA Draft Guidance on NAT tests to reduce the risks of HBV transmission from cells and tissues

Microbiological Safety of Human Cells, Tissues, and Cellular and Tissue-Based Products: FDA published a draft guidance on the "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus".

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25.02.16

Zika Virus and Blood Donations - Current Recommendations of the FDA

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.

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25.02.16

FDA publishes Draft Guidance for Industry "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products"

FDA's CBER published a Draft Guidance for Industry with recommendations and examples for "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under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".

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25.02.16

Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products

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".

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04.02.16

Guidance for Treponema pallidum Screening of donors of Human Cells and Tissues (HCT/Ps)

End of 2015, the FDA finalized their draft document and issued the 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)".

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04.02.16

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

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.

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04.02.16

FDA issues draft guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products

The US FDA published a draft guidance for Industry on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products which is supposed to provide recommendations for applying Title 21 of the Code of Federal Regulations.

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19.01.16

FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products

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.

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19.01.16

FDA publishes Guideline on Good Meeting Management Practice for Biosimilar Development

In November, the FDA published a Guideline on formal requesting, planning and performing meetings with the Agency with regard to the development and submission of biosimilars. Find out more about the FDA Guideline on Good Meeting Management Practice.

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09.12.15

FDA Guide for Microbial Vectors used for Gene Therapy

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".

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16.10.15

EDQM publishes Trends and Observations related to Blood and Blood Components

The EDQM has released a report with the goal to provide further insights into developments in the blood transfusion chain in Europe. Read more about these "Trends and observations on the collection, testing and use of blood and blood components in Europe."

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16.10.15

FDA Guidance on Transfusion and Transplantation - NAT based HLA Test Kits

Related to the increasing complexity of Human Leucocyte Antigen Testing methodolgy in the field of transfusion and transplantation, the FDA published a guidance document "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".

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