Animal Testing, Document and Research

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 Compliance

Analysis Chemical: 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 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

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

Agency IQ

NOVEMBER 27, 2023

ECHA issues research wish list to aid in its regulatory endeavors The European Chemicals Agency is attempting to guide scientific research toward topics with regulatory relevance. Second , ECHA is requesting further research addressing chemical pollution in the natural environment.

Animal Testing

Animal Testing Research Regulations 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. The most recent version of the document listing the categories is from 2010.

Animal Testing

Animal Testing Regulations Production Marketing

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

Agency IQ

JUNE 28, 2024

While the limited pre-market clinical data still must be “sufficient,” the document offers potential alternative clinical trial designs and statistical considerations. The document is organized into 10 sections, with the first four encompassing abbreviations and terminology, introduction, scope, and orphan device status.

Trials

Trials Marketing Clinical Trials Regulations

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

Agency IQ

AUGUST 18, 2023

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. To contact the author of this piece, email Rayan Bhargava.

International

International Regulations Packaging 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

FDA Modernization Act 2.0: A step in the right direction

Drug Discovery World

APRIL 12, 2023

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. The limitations of animal studies are widely documented.

FDA

FDA Animal Testing Cell Based Assays Clinical Trials

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. These rats, known as AA or P-lines, serve as animal models of alcoholism, exhibiting high alcohol-seeking behavior, withdrawal symptoms, and a predisposition to co-abuse ethanol and nicotine.

Research

Research Engineering Science Disease

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

Agency IQ

JANUARY 26, 2024

However, the agency has worked more recently on coating-specific guidance documents for other device types, including a final guidance from October 2019 on intravascular catheter systems with lubricious coatings. complete test reports do not need to be submitted to FDA).”

FDA

FDA Animal Testing Packaging Regulations

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

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Science Small Molecule Immune Response

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. For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ] This proposal is long overdue, as it was initially slated for the first quarter of 2023. [

Packaging

Packaging Regulations Laboratories Animal Testing

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. Drug discovery and development is an arduous process that can cost upwards of $2.6 million USD.

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

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. Key Documents and Dates Unified Agenda of Regulatory and Deregulatory Actions – Spring 2024

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 Featuring previous research by Walker Livingston.

FDA

FDA Packaging Science Drugs

Drug Discovery Digest

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

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

Trending Sources

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

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

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

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

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

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

FDA Modernization Act 2.0: A step in the right direction

Raising Welfare for Lab Rodents

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

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

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

Accelerating NDA filing through faster carcinogenicity assessment

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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