Animal Testing, Article and Regulations

Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

JULY 22, 2024

BY SCOTT STEPHENS, MPA 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. Fill out the form to read the full article.

Animal Testing

Animal Testing 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

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.

Animal Testing

Animal Testing Regulations Production Research

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The 3Rs Principles in Cosmetic and Self-care Industry: the Regulation that Prioritises Animal Welfare

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

Regulations Animal Testing Production Treatment

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. Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2).

Regulations

Regulations Animal Testing Production Marketing

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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

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

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

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. Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. Data outside the PMCF (section 9.4)

Trials

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

Animal Testing

Animal Testing Regulations Production Marketing

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

Agency IQ

JANUARY 26, 2024

For devices that are implanted and therefore intended to be in contact with the patient for long periods of time, the question of how materials hold up over time and interact with a patient’s system is a high priority one for device manufacturers and regulators.

FDA

FDA Animal Testing Packaging Regulations

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. This regulation has since been repealed and replaced with Implementing Regulation (EU) 2020/1740 , though many of the provisions and their articles remain the same.

Regulations

Regulations Animal Testing Government Production

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. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

International

International Regulations Packaging Animal Testing

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. Understanding how these two stages and types of CROs differ is fundamental to appreciating the intricate process of drug development.

Clinical Research

Clinical Research Clinical Trials Research Trials

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

The first co-published, peer-reviewed research paper between a commercial MPS provider and a regulator, demonstrates that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications, evidencing its enhanced performance versus standard techniques.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

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 Small Molecule Science Immune Response

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. 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.

Research

Research Engineering Disease Science

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. ” A recent article in The New Yorker suggests a solution to the problem. Free-range mice?

DNA

DNA Laboratories Engineering Animal Testing

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

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 It also means that most agencies covered by the bill will be required to absorb pay cost increases.”

FDA

FDA Packaging Science Drugs

Drug Discovery Digest

Commission unveils details on plan for phasing out animal testing for chemicals safety

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

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

Webinars

The 3Rs Principles in Cosmetic and Self-care Industry: the Regulation that Prioritises Animal Welfare

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

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

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

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

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

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

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

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

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

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

CN Bio’s PhysioMimix Technology Receives FDA Recognition

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

Raising Welfare for Lab Rodents

Everything Wrong with Mouse Studies (Kinda)

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

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

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