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 119

Research Engineering Disease Science 119

Drug Target Review

SEPTEMBER 10, 2024

Rapid delivery of IND-enabling Tox testing is crucial for a timely IND submission Advanced technologies enabling increasingly rapid timelines from vector construction to good manufacturing practice (GMP) manufacture brings the prospect of ever shorter timelines to IND readiness. FDA no longer has to require animal testing for new drugs.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

Agency IQ

JUNE 7, 2024

Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing.

Regulations 40

Regulations Animal Testing Production Marketing 40

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 40

FDA Science Small Molecule Immune Response 40

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. It obligates industry and the laboratories and testing facilities they employ to submit a notification to a database hosted by the CDPC when chemical safety assessments are commissioned.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Agency IQ

JUNE 28, 2024

Some of these are laboratory and animal tests, cadaveric studies and data from similar devices. The new guidance summarizes the requirements for performing a clinical evaluation for any medical device, which also apply to orphan devices (section 7).

Trials 40

Trials Marketing Clinical Trials Disease 40

Codon

MARCH 14, 2023

Leave a comment Let Me Count the Reasons… The Bible of mouse caretaking is called the Guide for Care and Use of Laboratory Animals. Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior. .”

DNA 52

DNA Laboratories Engineering Animal Testing 52

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

FDA 40

FDA Packaging Science Drugs 40

Codon

JUNE 2, 2024

These “fancy” varieties were then standardized in the 1920s by a small group of researchers at the Jackson Laboratory in Maine who intended to use them to investigate the genetics of cancer but were instead forced to sell their mice to support the lab when funding dried up during the Great Depression.

Laboratories 128

Laboratories Research Disease Science 128

Codon

NOVEMBER 1, 2024

” Nobody really knows without trying it out in the laboratory. Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. Subscribe to Asimov Press. There are a few reasons.

DNA 118

DNA RNA Molecular Biology Laboratories 118

Drug & Device Law

JULY 21, 2022

Citing various examples of live-saving drugs developed with animal testing, NABR noted that “[t]he vital role of animal research in advancing medicine cannot be overstated.”

Animal Testing 98

Animal Testing Research Laboratories Hospitals 98