Animal Testing, Disease and Regulations

Considering the use of animal models in drug development

Drug Discovery World

AUGUST 13, 2024

Professor Andy Whiting , CEO of Nevrargenics, asks whether animal models should be used as the default regulatory requirement and explores the times to use them. Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. Drugs developed in animals often fail in human studies.

Drug Development

Drug Development Animal Testing Regulations Drugs

Scottish drug discovery: advancing new research models

Drug Discovery World

MAY 25, 2023

The aim of the researchers is to understand the mechanisms that regulate cancer cell proliferation, survival and dissemination; to identify critical components of these pathways as targets for novel cancer therapies; and to help translate this knowledge to patient benefit.

Research

Research Drugs Virus Disease

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. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations

Regulations Animal Testing Production Marketing

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

Vial

MAY 20, 2024

Overview of Clinical CROs Clinical CROs, in contrast, are involved in the later stages of drug development, encompassing the more well-known stages of clinical research that involve testing a drug on human subjects from phase I to phase III or IV trials. billion in 2023 and is expected to grow at a CAGR of 7.0% between 2024 and 2030.

Clinical Research

Clinical Research Research Clinical Trials Laboratories

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

FDA

FDA Animal Testing Engineering Regulations

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. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.

Trials

Trials Marketing Clinical Trials Regulations

Advanced 3D cell-based technologies

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

Animal Testing Clinical Trials Pharmaceutical Companies FDA

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

A Compelling Need I was delighted to discover that the inspiration for Lume is a rare, recessive genetic disease, trimethylaminuria (TMAU), aka “fish odor syndrome.” If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. So the oft-elicited “clinically proven” is meaningless.

Disease

Disease Testimonials Production FDA

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. Ther Innov Regul Sci. Human neuronal cells: Possibilities in drug safety testing and beyond Avila AM, Bebenek I, Mendrick DL, Peretz J, Yao J, Brown PC. 2018;53(4):519–25.

Drugs

Drugs FDA Disease Animal Testing

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

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. Of course, AA and P-line rats are not the only research animals bred for the study of disease. 1 Subscribe to Asimov Press.

Research

Research Engineering Science Disease

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

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

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

They had “seen no evidence of [graft-versus-host disease] in any patient,” wrote surgeon Steven A. ” About 6% of all mouse genes are regulated in sex-specific ways. Each animal had a different microbiome. When the paper was published, surgeons in the U.S. A third experiment found no effect.

DNA

DNA Laboratories Animal Testing Engineering

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 The Tropical Disease Priority Review Voucher (PRV) program.

FDA

FDA Packaging Science Drugs

Drug Discovery Digest

Considering the use of animal models in drug development

Scottish drug discovery: advancing new research models

Trending Sources

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

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

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

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

Advanced 3D cell-based technologies

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

Human neuronal cells: possibilities in drug safety testing

Raising Welfare for Lab Rodents

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

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

Everything Wrong with Mouse Studies (Kinda)

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

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