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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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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. Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., 1, 2023, sesame.

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Kraft Heinz’s New Vegan Hot Dogs + How Precision Fermentation Could Revolutionize the Food Industry – Xtalks Food Podcast Ep. 151

XTalks

The products contain ingredients like bamboo fiber, pea protein and mushrooms. The study also highlights how genetically engineered microorganisms can inhibit the growth of foodborne pathogens. Additionally, the offerings have the distinctive “snap” of the outer casing and the savory smokiness of Oscar Mayer products.

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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. 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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BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

FDA Law Blog

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.

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Pfizer/BioNTech COVID jab works against Brazil variant; lab study

pharmaphorum

The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise a genetically engineered version of SARS-CoV-2 with the P.1 1 – that is worrying health officials around the world. . 1 mutations, as well as variants from the UK and South Africa.