2024, Animal Testing and Research - Drug Discovery Digest

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

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

A therapy candidate for fatal prion diseases turns off disease-causing gene

Broad Institute

JUNE 27, 2024

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. Previous research has shown that as little as 21 percent elimination of the protein can improve symptoms. Credit: Neumann EN, Bertozzi TM, et al.

Disease

Disease Therapies Engineering 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 Disease Science

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

This approach also requires an early identification of molecular liabilities and rheological properties, generally using research-grade material supply, in conjunction with in-silico modelling to de-risk drug formulation. FDA no longer has to require animal testing for new drugs. References: 1 Wadman M. 4 Berrie J, Donninger R.

Drug Development

Drug Development Clinical Supply Production Protein Expression

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

Agency IQ

JANUARY 26, 2024

BY LAURA DIANGELO, MPH | JAN 23, 2024 12:15 AM CST Orthopedic, implanted medical devices and coatings: Regulatory recap Medical device materials, and coating: In general, the types of materials and components of which medical devices are constructed need to be evaluated for their impact on a device’s performance and safety. What’s next?

FDA

FDA Animal Testing Packaging 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. The final rule is expected in April 2024. BY PATRICIA ISCARO, ESQ. |

Animal Testing

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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 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. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

Trials

Trials Marketing Clinical Trials Regulations

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

Agency IQ

JANUARY 19, 2024

BY RAYAN BHARGAVA, MSC | JAN 11, 2024 6:55 PM CST Regulatory background A 2019 fitness check of the most relevant chemical regulations found that protection afforded to human health and the environment was of a suitably high standard, although issues with consistency and efficiency were evident. ECHA will manage the notifications database.

Packaging

Packaging Regulations Laboratories Animal Testing

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

.” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” The chemo trial preceded Lume by more than a decade, so you’d think the product name would have been better researched. What’s the stink test?

Disease

Disease Production Testimonials FDA

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

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

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. increase in base salaries for federal workers in 2024, which started in January.

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. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

Regulations

Regulations FDA Science Production

Origins of the Lab Mouse

Codon

JUNE 2, 2024

It took another five years for a pair of American researchers to come up with an explanation before going on to pioneer the mouse as biomedicine’s premier model organism. It took another century after Mendel’s pea experiments for the mouse to become an established presence in research labs.

Laboratories

Laboratories Research Disease Science

Drug Discovery Digest

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

Trending Sources

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

A therapy candidate for fatal prion diseases turns off disease-causing gene

Raising Welfare for Lab Rodents

Rapid delivery of toxicological material

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

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

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

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

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

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

Levers for Biological Progress

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

Origins of the Lab Mouse

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