2023, Animal Testing, Research and Trials

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.”

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

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

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 Research Clinical Trials Laboratories

Why have medicines progressed so little in the last decades?

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. After all, these failures come on top of decades and decades of research into these diseases.

Animal Testing

Animal Testing Disease Trials Research

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Trials

Join DDW for the SLAS2024 Ignite Theater ‘Innovation from lab to patient’

Drug Discovery World

JANUARY 21, 2024

Inspired by the overall event theme of ‘Innovation at Every Turn’, the DDW track will present leading research and case studies from experts in academia, government agencies and the industry on how technology is innovating from bench to bedside, lab to patient. It is sponsored by Integra Biosciences and Hamamatsu Corporation.

Vaccine

Vaccine Computational Chemistry Animal Testing Engineering

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

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Read AgencyIQ’s analysis of those exemptions here.

Trials

Trials Marketing Clinical Trials Regulations

CN Bio named winner with most impactful industry collaboration

Drug Discovery World

NOVEMBER 23, 2023

Coupled with increasing awareness around ethical considerations and the increasing cost of animal studies, there is growing interest in New Approach Methodologies (NAMs), such as OOC, to provide effective, predictive preclinical models.

Animal Testing

Animal Testing FDA Clinical Trials Government

Experimental vaccine protects against deadly Sudan virus

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease. Next, the researchers tested the safety and efficacy of VSV-SUDV in macaques.

Virus

Virus Vaccine Immune Response Licensing

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. Cell Stem Cell. 2017 Jul 6;21(1):14–7.

Drugs

Drugs FDA Disease Animal Testing

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

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

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising. 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.

Disease

Disease Testimonials Production FDA

Drug discovery hotspots: What is the secret to Switzerland’s success? (part 2)

Drug Discovery World

JULY 3, 2024

DDW’s Diana Spencer takes a closer look into why Switzerland is such a life sciences powerhouse and how Swiss researchers are advancing new technology and tackling modern health challenges. Swiss companies are also applying AI beyond preclinical drug discovery, to clinical trials and upskilling staff.

Drugs

Drugs Clinical Trials Science Therapies

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. DDW Volume 24 – Issue 2, Spring 2023 References Testing for Carcinogenicity of Pharmaceuticals.

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

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

The agency received $3,530,150,000 in direct appropriations for salaries and expenses in FY 2023, and requested $3,896,028,000 billion for FY 2024 – but is receiving $3,522,150,000 from Congress for this year (note: again, this does not include user fee program funding). One issue here: FDA staff salaries.

FDA

FDA Packaging Science Drugs

Drug Discovery Digest

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

New Alternative Methodologies and Their Applications in Drug Discovery and Development

Trending Sources

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

Why have medicines progressed so little in the last decades?

Drug repurposing: The benefits, risks and what we learned from Covid-19

Join DDW for the SLAS2024 Ignite Theater ‘Innovation from lab to patient’

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

CN Bio named winner with most impactful industry collaboration

Experimental vaccine protects against deadly Sudan virus

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

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

Drug discovery hotspots: What is the secret to Switzerland’s success? (part 2)

Accelerating NDA filing through faster carcinogenicity assessment

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

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