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The 3Rs Principles in Cosmetic and Self-care Industry: the Regulation that Prioritises Animal Welfare

biobide

Cruelty-free cosmetics have emerged as a powerful statement within the beauty industry and Fast Moving Consumer Goods (FMCG), reflecting a growing consumer consciousness on the ethical treatment of animals. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2018;53(4):519–25. 2023 Mar;139:105345.

Drugs 111
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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

In the field of clinical research , this pipeline can be broken down into several stages and processes specifically designed to rigorously validate the safety and efficacy of new drugs and treatments. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

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Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

For devices that are implanted and therefore intended to be in contact with the patient for long periods of time, the question of how materials hold up over time and interact with a patient’s system is a high priority one for device manufacturers and regulators.

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

Agency IQ

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. The device description should include information about the current state of the art treatment options and any alternative device choices. Appendix A.2

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

Agency IQ

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.

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Raising Welfare for Lab Rodents

Codon

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.

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