Remove Animal Testing Remove Article Remove Treatment
article thumbnail

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.

article thumbnail

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

Agency IQ

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. The device description should include information about the current state of the art treatment options and any alternative device choices. Data outside the PMCF (section 9.4) These data may help detect rare complications.

Trials 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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. What is a Pre-Clinical CRO?

article thumbnail

CN Bio named winner with most impactful industry collaboration  

Drug Discovery World

Since then, the breadth and scope of the study has been expanded twice to investigate additional models for increasingly complex studies that aim to better inform decision-making at an earlier stage of drug discovery, gain deeper mechanistic insights to refine in vivo study assay design and reduce requirements for animal models.

article thumbnail

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

Agency IQ

Finally, the agency recommends bench testing for evaluating the effect of the coating process on the device’s performance, including comparative physical and chemical testing of the coated substrate and comparative fatigue testing of the coated substrate.

FDA 40
article thumbnail

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.

FDA 40
article thumbnail

Raising Welfare for Lab Rodents

Codon

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. 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.

Research 119