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FDA Developments on Biosimilars

The FDA has published a comprehensive guidance recommendation to assist biosimilar applicants with manufacturing changes. Through the question-and-answer format, the FDA provides insights and recommendations to promote the development of these important therapeutic alternatives, while also seeking to collaborate with industry to effectively shape future biosimilar guidance.

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Revision of USP Chapter <1033> on Validation of Biological Assays published

Validation of Bioassays - after a rejected attempt to revise Chapter <1033> at the end of 2022, the USP is now publishing a draft revision based on the currently still official version from 2013.

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Next Generation of Genome Editing?

Researchers at the Arc Institute have developed a new genome editing technique that enables DNA rearrangements with greater precision. This discovery, based on the use of a unique "bridging RNA", could radically change the future of genome design. This discovery was recently published in two papers in the journal Nature. How does this new genome editing mechanism work?

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A further Step for the SoHO Regulation

At the end of May, the EU member states adopted the new SoHO Directive, meaning that transposition and implementation of the regulations on substances of human origin (SoHO) are continuing. Find out what the regulation contains and what the next steps are.

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Update of Guideline on Epidemiological Data

The European Medicines Agency (EMA) has released a concept paper on the revision of the guideline on epidemiological data on blood transmissible infections for public consultation.

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Final Approval of SoHO Regulation

On 24 April 2024, the EU Commission finally approved the regulation “Quality and safety standards for substances of human origin for human use”.

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FDA Warning Letter to a Biotechnology Company in China

During an investigation by the FDA, several CGMP violations were identified, which may lead to the denial of importation of drug products into the United States.

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HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"

In Pharma Europe, the publication of a draft of the new chapter "2.6.41 High-throughput sequencing for the detection of viral extraneous agents" represents a step forward in two important areas. Firstly, with regard to the viral safety of medicinal products and secondly, with regard to the regulatory establishment of modern detection methods.

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FDA Warning Letter on misbranded and unapproved Drugs

Due to ignorance of the FDA definition of drugs, a US pharmaceutical company has received a Warning Letter regarding their products.

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New Regulation on Blood, Blood Products and Plasma

News on the Regulation on standards of quality and safety of substances of human origin (SoHO). The regulation are intended to help ensure that the donation and processing of blood, blood products and plasma reflect the latest legal, political and scientific standards.

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