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 40

Animal Testing Regulations Production Research 40

Drugs.com

AUGUST 8, 2024

animal testing, wounds treated with electric bandages healed 30% faster than wounds treated with conventional. FRIDAY, Aug. 9, 2024 -- Newly developed battery-powered electric bandages could help wounds heal more quickly, a new study reports.In

Animal Testing 98

Animal Testing 98

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.

Animal Testing 40

Animal Testing Research 40

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.

Animal Testing 40

Animal Testing Regulations Production Research 40

biobide

JUNE 8, 2023

It is fast becoming a cost-effective and efficient alternative to animal testing. The in silico method represents an increasing role in drug discovery as technology becomes more sophisticated. It can be used in all stages of drug discovery, from screening to pre-clinical trials and greatly reduces drug development time.

Animal Testing 83

Animal Testing Clinical Trials Drugs Drug Development 83

biobide

AUGUST 18, 2023

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

Regulations 92

Regulations Animal Testing Production Treatment 92

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. Fill out the form to read the full article.

Animal Testing 59

Animal Testing 59

Drug Target Review

MARCH 18, 2024

These models can be used for more efficient and effective drug testing early in the development process, potentially reducing the need for animal testing and later-stage human trials that are both costly and time-consuming.

Marketing 59

Marketing Animal Testing Engineering Drug Development 59

Crown Bioscience

APRIL 12, 2023

The development of new drugs and biological products has traditionally mandated animal testing, but the FDA Modernization Act 2.0 allows for alternative non-clinical testing, allowing reliable alternatives for drug discovery and biological product applications.

Animal Testing 52

Animal Testing Drugs FDA Production 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

FDA Law Blog: Biosimilars

MARCH 19, 2024

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application.

Animal Testing 59

Animal Testing Laboratories Marketing Regulations 59

Reprocell

MARCH 6, 2023

expands the range of models that can be used to test a compound before clinical trials. 1 Under this new law animal testing can still be used, but alternative testing methods now also represent a legitimate option. With support from over 200 organizations, the "FDA Modernization Act 2.0"

FDA 52

FDA Animal Testing Clinical Trials Trials 52

Drug Target Review

MARCH 11, 2024

How can this finding potentially reduce the reliance on animal testing in the field of cancer drug testing? 3D printing allows innovators to produce complex structures and intricate organ models, which can be used to study diseases and test new therapies in a more realistic and efficient manner.

Animal Testing 111

Animal Testing Therapies Clinical Trials Research 111

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?

FDA 52

FDA Animal Testing Science Drug Development 52

Predictive Oncology

AUGUST 8, 2024

Most drug failures occur in Phase II and Phase III clinical trials when drugs move from immortalized cell lines and animal testing to human patients. One of the primary reasons for these late-stage failures is that the heterogeneity of human subjects is not introduced until clinical trials are already underway.

Drug Development 52

Drug Development Clinical Trials Animal Testing Trials 52

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.

Animal Testing 40

Animal Testing Research Regulations Compliance 40

Broad Institute

JUNE 27, 2024

Thanks to these creative solutions, the researchers now have a highly effective epigenetic editor that is small enough to deliver to the brain, and that appears in cell culture and animal testing to have low toxicity and limited off-target effects. “It’s been a privilege to be part of this; it’s pretty rare to go from basic research to therapeutic (..)

Disease 142

Disease Therapies Engineering Clinical Trials 142

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.

Drugs 111

Drugs FDA Disease Animal Testing 111

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.”.

FDA 40

FDA Animal Testing Clinical Trials Pharmaceuticals 40

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.

FDA 45

FDA Animal Testing Engineering Regulations 45

Advarra

JUNE 20, 2023

Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors. Often, medical innovations are first explored in oncology research (e.g.,

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

Agency IQ

OCTOBER 12, 2023

It also found this approach beneficial because it reduces the need for animal testing. In other words, CHP-methyl and chlorpyrifos are close enough in structure to be appropriate for EFSA to leverage data from the latter to inform the regulation of the former, bypassing the need for redundant animal testing in the process.

Regulations 40

Regulations Animal Testing Government Production 40

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.

Animal Testing 40

Animal Testing Pharmaceuticals Disease Research 40

Drug Target Review

OCTOBER 3, 2024

FDA no longer needs to require animal tests 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. ‌

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Vial

MAY 20, 2024

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.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

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.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

Agency IQ

JUNE 7, 2024

Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing.

Regulations 40

Regulations Animal Testing Production Marketing 40

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 40

FDA Small Molecule Science Immune Response 40

Agency IQ

JANUARY 26, 2024

Finally, the agency recommends bench testing for evaluating the effect of the coating process on the device’s performance, including comparative physical and chemical testing of the coated substrate and comparative fatigue testing of the coated substrate.

FDA 40

FDA Animal Testing Packaging Regulations 40

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

FDA 64

FDA Packaging Animal Testing Production 64

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. |

Animal Testing 40

Animal Testing Regulations Production Marketing 40

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

Therapies 59

Therapies FDA Production Disease 59

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 112

Research Engineering Disease Science 112

Agency IQ

AUGUST 18, 2023

E Evidence of Non-carcinogenicity for Humans Agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animal studies.

International 40

International Regulations Packaging Animal Testing 40

Agency IQ

MARCH 7, 2024

At the same time, Hojsik pointed to the positive impact that the 1S1A ambition should have on data sharing, thereby reducing animal testing, another objective of the Green Deal. Streamlining these processes, according to the proposal, should improve transparency and reduce administrative efforts for stakeholders.

Regulations 40

Regulations International Government Compliance 40

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Agency IQ

JUNE 28, 2024

Some of these are laboratory and animal tests, cadaveric studies and data from similar devices. The new guidance summarizes the requirements for performing a clinical evaluation for any medical device, which also apply to orphan devices (section 7).

Trials 40

Trials Marketing Clinical Trials Regulations 40