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On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animaltesting in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).
The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animaltesting in the development of monoclonal antibodies and other drugs, when scientifically appropriate. References Animal Legal Defense Fund v. Federal ruling on USDA primate welfare petition, 2023.
Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animaltesting — I hope others will take on these challenges in similar essays. bioRxiv (2023). This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.
In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animaltesting not eliminate animaltesting in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animaltesting.
Where possible, NAM s seek to avoid the use of animaltesting or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animaltesting at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.
Commission unveils details on plan for phasing out animaltesting for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animaltesting used for chemical safety assessment.
BY RAYAN BHARGAVA, MSC | NOV 17, 2023 4:53 PM CST Regulatory background The European Partnership for the Assessment of Risks from Chemicals (PARC) is the seven year program, lasting from 2022 to 2029, which aims to facilitate, share, and improve research on chemical risk assessment.
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 animaltesting to establish drug safety and effectiveness. 2023 Mar;139:105345. cited 2023 Jun 15]. Regul Toxicol Pharmacol RTP. Rockley KL.
BY RAYAN BHARGAVA, MSC | OCT 6, 2023 4:30 PM CDT Regulatory background Chlorpyrifos-methyl (CHP-methyl) is an insecticide with applications for a variety of crops. It also found this approach beneficial because it reduces the need for animaltesting.
FDA no longer has to require animaltesting for new drugs. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al. 2023 Jan-Dec;15(1):2220150. References: 1 Wadman M. Rapidly accelerated development of neutralizing COVID-19 antibodies by reducing cell line and CMC development timelines. Biotechnol Bioeng. 2022 Dec 8:10.1002/bit.28302
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 animaltesting.
FDA no longer needs to require animaltests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al. Antibodies to watch in 2024. 2024 Jan 5;16(1). www.science.org. Available from: [link] Baker M. Reproducibility crisis: Blame it on the antibodies. 2015 May;521(7552):274–6.
billion in 2023 and is expected to grow at a CAGR of 7.0% One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. between 2024 and 2030.
BY RAYAN BHARGAVA, MSCAUG 16, 2023 10:33 AM CDT International: World Health Organization The International Agency for Research on Cancer (IARC) classification framework is particularly well-known , consisting of four levels of increasing certainty regarding human cancer risk. please read AgencyIQ’s August 8, 2023 article here.]
This also has clear potential to reduce animaltesting, another key commitment made by the Commission. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [ For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ]
The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animaltesting for assessing risk of injury to health or the environment. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.
A question-and-answer document answers common questions on clinical investigation ( read AgencyIQ’s analysis of MDCG 2021-6 here ), and a Commission guidance ( 2023/C 163/06 ) outlines the content and structure of the clinical investigation report summary. Read AgencyIQ’s analysis of those exemptions here.
Commission redoubles commitment to reduce animaltesting in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animaltesting within the cosmetics and chemical sectors.
President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. As a result, the FDA is now required to consider alternatives to animaltesting, such as in vitro , in silico , and in chemico tests and models.
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 animaltesting. Nonclinical studies encompass much more than just animal studies.
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.
The agency received $3,530,150,000 in direct appropriations for salaries and expenses in FY 2023, and requested $3,896,028,000 billion for FY 2024 – but is receiving $3,522,150,000 from Congress for this year (note: again, this does not include user fee program funding). One issue here: FDA staff salaries.
A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising. ” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”
For example, the FDA does not have a proposed rule listed that would change how it regulates animaltesting requirements following the passage of the FDA Modernization Act 2.0 It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. and the E.C.
These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices. The FDA has taken recent steps that may, or may not, affect product liability litigation. We’re discussing the “may” aspect. of the human body” for at least 30 days).
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