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FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing 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).

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Future-proofing drug development with GenAI

Drug Target Review

JULY 3, 2025

With up to 90 percent of assets never making it to market when competition is at an all-time high, it is worth discussing how AI-driven approaches might help set a stronger foundation for possibilities downstream. FDA news release, “FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs.”

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Time for change: non-human primates in drug research

Drug Target Review

JULY 7, 2025

The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs, when scientifically appropriate. NIH Office of Laboratory Animal Welfare – Training Guidelines. Bailey J, et al.

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A global push for better animal welfare in research

Drug Target Review

JUNE 13, 2025

Complex challenges in reducing animal use One of the most pressing issues Liz highlights is the misconception that animal testing can be eliminated entirely in the near future. Microphysiological systems and other non-animal models are incredibly promising, but they’re not a total replacement,” she cautions.

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Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. The Omnibus Regulation has four main articles reattributing responsibilities across the four EU agencies primarily concerned with chemical regulation. Article 3 redirects tasks to ECHA regarding medical devices.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

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Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

FDA

FDA Animal Testing Packaging Regulations

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Agency IQ

JANUARY 12, 2024

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 animal testing for assessing risk of injury to health or the environment. BY PATRICIA ISCARO, ESQ. |

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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

MARCH 7, 2024

The “Collaboration” session, the subject of this article, encompassed three smaller segments – two shorter one-on-one interviews, and a one-hour panel discussion with representatives from EU government, trade associations, and the non-profit sector. see AgencyIQ’s article here for background on 1S1A.] “If

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Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Agency IQ

NOVEMBER 27, 2023

The next key area concerns the ongoing shift away from animal testing. For example, under the REACH (1907/2006/EC) and CLP (1272/2008/EC) regulations, NAMs are generally only used to replace animal testing for hazard identification and classification of skin sensitizers.

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Animal Testing Research Regulations Compliance

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

MAY 20, 2024

In this article, we will define preclinical and clinical CROs, as well as highlight the unique needs and challenges of these organizations in their respective stages of drug research. The global preclinical CRO market was estimated to be valued at US$5.7 What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

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CN Bio’s PhysioMimix Technology Receives FDA Recognition

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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Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

Agency IQ

OCTOBER 12, 2023

EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process The General Court of the European Union this week upheld the non-renewal of market authorization for chlorpyrifos-methyl used as an active substance in pesticides. In particular, article 13 describes the role of an EFSA conclusion in the renewal process.

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Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing 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 animal testing within the cosmetics and chemical sectors.

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

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.

FDA

FDA Science Small Molecule Immune Response

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 The Tropical Disease Priority Review Voucher (PRV) program.

FDA

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Origins of the Lab Mouse

Codon

JUNE 2, 2024

Read our full Editors’ Note and preview upcoming articles by clicking here. Read this article on our website by clicking here. 2 An 1898 article describes the show mouse as “larger than the common household specimen. Today we launch Issue 03 of Asimov Press.

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Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. It’s also interesting to see what isn’t on this list. and the E.C.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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Animal Testing FDA Analytical Chemistry International

Gylden’s gold platform trains T cells to kill viruses

Drug Target Review

APRIL 9, 2025

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. Preclinical and early clinical data A key question in vaccine development is how well a vaccine performs in preclinical and early-stage human trials.

Virus

Virus Vaccine RNA Trials

Drug Discovery Digest

FDA Eliminates Animal Testing: Impact on Biotechs

Future-proofing drug development with GenAI

Trending Sources

Time for change: non-human primates in drug research

A global push for better animal welfare in research

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

CN Bio’s PhysioMimix Technology Receives FDA Recognition

Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Origins of the Lab Mouse

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

Gylden’s gold platform trains T cells to kill viruses

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