Animal Testing, Presentation and Regulations

Animal Testing

Presentation

Regulations

New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

SEPTEMBER 29, 2023

Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing 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.

Animal Testing

Animal Testing Drugs Pharmacokinetics Regulations

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.

Animal Testing

Animal Testing Regulations Production Research

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Bridging Innovation & Patient Care: The Growing Role of AI

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

Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

Animal Testing

Animal Testing Research Regulations Compliance

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Bridging Innovation & Patient Care: The Growing Role of AI

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

These results are presented in table 1, alongside rodent hippocampal slice data, which are frequently used in projects where issues with seizure are anticipated. which is expressed on inhibitory GABAergic neurons, and less potently inhibits other Kv channels present on excitatory neurons. Ther Innov Regul Sci. 2018;53(4):519–25.

Drugs

Drugs FDA Disease Animal Testing

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

Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. The firms presented a multipronged argument seeking an annulment of the non-renewal of CHP-methyl for a handful of reasons.

Regulations

Regulations Animal Testing Government Production

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

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations

Regulations Animal Testing Production Marketing

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Now the agency will never imply that an agent does not present cancer risk, only that it either is a carcinogen or is simply not classifiable as one with the present level of evidence.

International

International Regulations Packaging Animal Testing

The essential role of recombinant phage display antibody libraries

Drug Target Review

OCTOBER 3, 2024

Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2024 Jan 5;16(1).

Molecular Biology

Molecular Biology Pharmacokinetics Laboratories Animal Testing

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research

Research Engineering Disease Science

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

Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

Packaging

Packaging Regulations Laboratories Animal Testing

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

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations

Regulations International Government Compliance

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. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

Animal Testing

Animal Testing Regulations Production Marketing

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

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

Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.

Trials

Trials Marketing Clinical Trials Disease

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.

Animal Testing

Animal Testing FDA Analytical Chemistry International

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

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

Drug Discovery Digest

New Alternative Methodologies and Their Applications in Drug Discovery and Development

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

Webinars

Trending Sources

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

Webinars

Human neuronal cells: possibilities in drug safety testing

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

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

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

The essential role of recombinant phage display antibody libraries

Raising Welfare for Lab Rodents

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

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

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

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

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

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

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

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