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FDA - Blood Collection and Zika Virus in Florida

Related to some non-travel related cases of Zika virus, the FDA published a new "Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida".

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EMA publishes Reflection Paper on Viral Safety of plasma-derived Medicinal Products with Respect to Hepatitis E Virus

The EMA published the final "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus" after the completion of the accepted comments of the public consultation.

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New Orientation for ECA Foundation RMM Working Group

The ECA Foundation's Rapid Microbiological Methods (RMM) Working Group was originally established in June 2006 at the Paul-Ehrlich-Institut (PEI) - the German Federal Agency for Vaccines and Biomedicines. Now the Foundation announced a new orientation for its RMM Working Group.

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EDQM Survey on new General Chapter on microbiological Control of Tissue

The European Directorate for the Quality of Medicines & Healthcare (EDQM) published a survey to gather information from relevant stakeholders for elaboration of a chapter on microbiological control of tissues.

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Revision of BAM Chapter 23: Microbiological Methods for Cosmetics

In May 2016, the FDA published some revisions in the text of the Bacteriological Analytical Manual, Chapter 23, "Microbiological Methods for Cosmetics".

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EDQM announces revision of general chapter Monocyte Activation Test (2.6.30)

On 23 June, the EDQM in Strasbourg announced the revision of the pharmacopoeial general chapter 2.6.30 on Monocyte Activation Test.

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Q&A - Reducing the Risk of Transfusion-Transmission of Zika Virus

In addition to their Guidance on donor screening and deferral concerning the risk of ZIKA virus transmission, the FDA now published a Q&A documenmt to answer the common questions of blood establishments. Read more about the "Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry”.

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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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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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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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