The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

Animal Testing 52

Animal Testing FDA Drug Development Production 52

Drug Target Review

SEPTEMBER 10, 2024

To achieve an aggressive timeline from DNA to investigational new drug (IND) application, drug developers have strengthened collaborations with contract development & manufacturing organisations (CDMOs) to expedite drug development. FDA no longer has to require animal testing for new drugs. References: 1 Wadman M.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

Agency IQ

OCTOBER 12, 2023

In particular, they discussed the potential for genotoxicity, or the potential to damage human DNA, and developmental neurotoxicity, or the negative effect on the developing human nervous system. It also found this approach beneficial because it reduces the need for animal testing.

Regulations 40

Regulations Animal Testing Government Production 40

Broad Institute

JUNE 27, 2024

Unlike gene editing, this “epigenetic” editing does not modify the underlying DNA sequence, but it should switch the gene off permanently, which means that this could be a one-time treatment. Like Cas9, ZFPs can serve as guide proteins to direct the tool to a target site in DNA.

Disease 142

Disease Therapies Clinical Trials Engineering 142

The Premier Consulting Blog

APRIL 25, 2023

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

FDA 52

FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research 122

Research Engineering Disease Science 122

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 post How Lume Whole Body Deodorant Was Inspired by a Genetic Disease appeared first on DNA Science. An objective assessment of odor would be nice.

Disease 89

Disease Testimonials Production FDA 89