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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus. Why Does the IBC Need to do a Risk Assessment?

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This week in drug discovery (8-12 April) 

Drug Discovery World

The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. News round-up for 8-12 April by DDW Digital Content Editor Diana Spencer.

Drugs 52
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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. 1, 2023, sesame.

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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Originally released in 1976, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) serve as the foundation of biosafety-focused oversight of research involving recombinant or synthetic nucleic acids (rsNA). Since then, however, certain genetic engineering technologies (e.g.,

Genome 52
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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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More efficient mouse model generation through informed founder selection

Drug Discovery World

This paid-for advertorial by Taconic appeared in DDW Volume 24 – Issue 3, Summer 2023 Overcoming challenges in model generation Genetically engineered mouse models are essential tools for biomedical research. In response, researchers often breed several founders.

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Trends in Human Health Management: A Journey through Time

Roots Analysis

The famous Indian physician, Sushruta, wrote the Sushruta Samhita , a medical guide that contains descriptions of approximately 1120 illnesses, 700 medicinal plants, 64 medicinal preparations from mineral sources and 57 therapeutic preparations from animal sources.