Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. What are nonclinical studies and when are they conducted in drug development?

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Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

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Codon

JULY 21, 2024

There is an enormously high bar for morally permissible human subjects research , but when it comes to animals, the bar is much lower. 2 This is understandable given how much we value human life, but solutions to this disparity are not zero-sum: we can also do better for animals. In fact, the science of animal welfare is exploding.

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Drug Target Review

APRIL 9, 2025

In the fast-moving world of drug discovery and vaccine development, the most transformative breakthroughs often emerge where cutting-edge science meets bold innovation. Rademacher explained that their approach bypasses the need for traditional animal testing: Everybody asks us why we don’t test our vaccines in monkeys and rabbits.

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Drug Target Review

SEPTEMBER 26, 2023

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Ther Innov Regul Sci. 2018;53(4):519–25.

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The Pharma Data

JANUARY 11, 2021

By adopting these powerful systems, we are offering an option to help replace, reduce, refine the number of animal tests and the potential to benefit patients through the provision of safer and more efficacious therapeutics.”. ‘Impact of organ-on-a-chip technology on pharmaceutical R&D costs’ [link].

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The Pharma Data

MAY 15, 2023

By mirroring human and disease biology more accurately than animal models, they can also help reduce the reliance on animal testing. Human model systems are miniature 2D or 3D living ‘replicas’ of human tissues and organs that scientists create from human stem cells.

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FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Bench Model Testing “Testing using model systems with representative materials, geometries, and/or other simulated use parameters to evaluate the implant and demonstrate SE.” We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

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Drug Target Review

SEPTEMBER 10, 2024

FDA no longer has to require animal testing for new drugs. References: 1 Wadman M. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al. Rapidly accelerated development of neutralizing COVID-19 antibodies by reducing cell line and CMC development timelines.

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Agency IQ

JANUARY 19, 2024

The science that informs various chemical regulations originates from scientific committees, expert groups, Commission departments or contractors, and, most often, from the four main EU agencies overseeing chemical regulation. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

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Agency IQ

MARCH 7, 2024

The third and fourth sessions – representing the “Science” and “Knowledge” themes of the conference – were each an hour in length and comprised discussions by two other expert panels. AgencyIQ will summarize these other sessions in a subsequent piece.

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PLOS: DNA Science

APRIL 4, 2024

.” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” The post How Lume Whole Body Deodorant Was Inspired by a Genetic Disease appeared first on DNA Science. An objective assessment of odor would be nice.

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Codon

MARCH 14, 2023

Mice and rats account for 95 percent of all animals used in biomedical research. More than 120 million mice are apparently killed each year in the name of science. For every 5,000 drug compounds tested in mice, five move into human studies. Each animal had a different microbiome. A third experiment found no effect.

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Agency IQ

MARCH 7, 2024

The first package of bills covers six different areas, including Veterans Affairs ; Agriculture and the FDA ; Commerce, Justice and Science ; Energy and Water Development ; the Interior and Environment , and Transportation, Housing and Urban Development.

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Codon

JUNE 2, 2024

Or, as an 1898 article in the Reading Eagle about the spread of mouse fancying from Britain to America puts it: “The latest addition to the ranks of pet animals is the mouse, and, strange to say, many women are among those who are interested in it.” This raises a question: what is the purpose of biomedical science?

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The Pharma Data

OCTOBER 27, 2020

The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests, the AP reported. California-based Gilead Sciences Inc. Lilly and Regeneron have both asked for emergency use authorization from the U.S. Food and Drug Administration.

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Agency IQ

JULY 12, 2024

Perhaps the most important changes to FDA’s agenda relate to updates regarding when certain major rules are expected to be released The next few months of anticipated FDA rulemaking do not contain much that would be considered controversial to most segments of the life sciences sector. It’s also interesting to see what isn’t on this list.

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Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. There are more than 500,000 life sciences researchers in the U.S., Subscribe to Asimov Press.

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