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FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

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New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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FDA publishes Information and Reviews of Biological Research Projects

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

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FDA - Notification of Deviations in Cell and Tissue Products

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.

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EMA - Public Meeting on COVID-19 Vaccines

Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.

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Coronavirus: FDA's Advice for the Donation of Cells, Tissue and Products Based on Them

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

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Serological Tests for HTLV Viruses by Blood and Blood Components

Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.

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Updated Recommendations for Reducing the Risk of CJD and vCJD by Blood and Blood Components

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.

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Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceutical Products

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.

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Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

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