Animal Testing, Drug Development and FDA

77% of researchers not using alternatives to animal testing

Drug Discovery World

JULY 15, 2024

New survey findings have revealed that 77% of R&D professionals are not using in vitro cell-based alternatives to animal testing, and only 23% describe themselves as ‘very familiar’ with any kind of animal model alternative. This comes despite new laws, such as the FDA Modernization Act 2.0

Animal Testing

Animal Testing Research Pharma Companies Regulations

Kidney-tissue platforms could reduce animal testing in toxicology studies

Drug Discovery World

FEBRUARY 21, 2024

Kidney disease researchers at the University of Washington will use a multimillion-dollar federal grant to advance drug development platforms that would reduce reliance on animal tests. The FDA Modernization Act 2.0 The investigators, in the UW schools of Medicine and Pharmacy, received the $7.3

Animal Testing

Animal Testing Pharmacy FDA Engineering

FDA expands organ-on-a-chip research collaboration

Drug Discovery World

JANUARY 18, 2023

The US Food and Drug Administration (FDA) and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ microphysiological systems (MPS) using the PhysioMimix Multi-organ System. . Changes to rules for animal testing . Recreating the in vitro structure of tissues.

FDA

FDA Animal Testing Research Drug Development

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

Closing the translation gap in oncology drug development

Drug Discovery World

MAY 9, 2023

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Drug Development

Drug Development Clinical Trials Animal Testing Cell Based Assays

Analysis Life Sciences: 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.

FDA

FDA Animal Testing Science Production

Beyond animal testing: The rise of organoids in toxicology research

Drug Discovery World

MARCH 20, 2024

Around 30% of drugs show adverse reactions during human clinical trials despite promising pre-clinical studies. One of the major causes of the high attrition rate is the poor predictive value of current preclinical models used in drug development. billion for bringing a new drug to market, a process extending over a decade.

Animal Testing

Animal Testing Research Clinical Trials Drug Development

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

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. Furthermore, DILIsym predicted that a related drug, ubrogepant, would be relatively safe for the liver.

Animal Testing

Animal Testing Disease Trials Research

What does the FDA animal testing legislation mean for drug discovery?

Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. Ultimately, the FDA Modernization Act 2.0

Animal Testing

Animal Testing FDA Clinical Trials Drugs

Scottish drug discovery: advancing new research models

Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. With over 150 pharma services/supply companies and 19 universities, Scotland is one of the most advanced life science sectors in the UK and the world.

Research

Research Drugs Virus Disease

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

Vial

MAY 20, 2024

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. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

Clinical Research

Clinical Research Research Clinical Trials Laboratories

FDA Modernization Act 2.0: A step in the right direction

Drug Discovery World

APRIL 12, 2023

By DDW Editor Reece Armstrong A lot has already been said about the US Food and Drug Administration’s (FDA) Modernization Act 2.0 The decision by the Biden administration to end the federal requirement for drugs under development to be tested on animals represents a significant step forward for the life sciences sectors.

FDA

FDA Animal Testing Cell Based Assays Clinical Trials

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., 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.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. Tobolowsky — Much has changed since the long-gone days of 2017.

FDA

FDA Packaging Animal Testing Production

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Clinical Supply

Clinical Supply Drug Development Production Animal Testing

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

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

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. Drug discovery and development is an arduous process that can cost upwards of $2.6 This stage is more highly regulated and consists of both preclinical testing and clinical trials.

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

Origins of the Lab Mouse

Codon

JUNE 2, 2024

” It’s an uncharitable take, but when drugs fail as often as they do despite animal testing, it’s not hard to see the JAX mice as a metaphor for a biomedical enterprise cloistered away from the real world. The FDA itself believes these types of early human studies are underutilized.

Laboratories

Laboratories Research Disease Science

Drug Discovery Digest

77% of researchers not using alternatives to animal testing

Kidney-tissue platforms could reduce animal testing in toxicology studies

Trending Sources

FDA expands organ-on-a-chip research collaboration

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

Closing the translation gap in oncology drug development

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

Beyond animal testing: The rise of organoids in toxicology research

Exploring alternatives to animal testing in drug discovery

Why have medicines progressed so little in the last decades?

What does the FDA animal testing legislation mean for drug discovery?

Scottish drug discovery: advancing new research models

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

FDA Modernization Act 2.0: A step in the right direction

Advanced 3D cell-based technologies

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

Rapid delivery of toxicological material

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

Human neuronal cells: possibilities in drug safety testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

Accelerating NDA filing through faster carcinogenicity assessment

Origins of the Lab Mouse

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