Animal Testing, Regulations and Research

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

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research

Clinical Research Clinical Trials Research 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 Disease Science

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 27,28 Since the advent of hiPSC technology almost two decades ago enormous progress has been made in many areas of research. Ther Innov Regul Sci. 2018;53(4):519–25.

Drugs

Drugs FDA Disease Animal Testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

CAMBRIDGE, England–( BUSINESS WIRE )– CN Bio , a leading developer of single and multi organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, today announced the publication of co-authored research with the U.S. Food and Drug Administration (FDA) 1.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

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

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 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

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

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. What’s the stink test? I couldn’t find such studies.

Disease

Disease Production Testimonials FDA

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 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

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. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

Trials

Trials Marketing Clinical Trials Disease

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

Mice and rats account for 95 percent of all animals used in biomedical research. For every 5,000 drug compounds tested in mice, five move into human studies. About 80% of drugs are tested only on male mice. .” ” About 6% of all mouse genes are regulated in sex-specific ways. I can only shower so often!

DNA

DNA Laboratories Engineering 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 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

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. These directions highlight some key topics in regulatory policy.

FDA

FDA Packaging Science Drugs

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

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Still, many of the bottlenecks slowing biology today are biophysical , rather than computational.

DNA

DNA RNA Molecular Biology Laboratories

Drug Discovery Digest

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

Raising Welfare for Lab Rodents

Trending Sources

Human neuronal cells: possibilities in drug safety testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

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

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

New Alternative Methodologies and Their Applications in Drug Discovery and Development

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

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

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

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

Everything Wrong with Mouse Studies (Kinda)

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

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

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

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

Levers for Biological Progress

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