August 2017
Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond
August 28, 2017The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative...
Introducing the 3R Concepts into Pre-College Classrooms
August 28, 2017This poster provides a snapshot of pre-college teachers (46) within the U.S.—gauging their knowledge and familiarity of the 3Rs and non-animal testing methods (i.e. in vitro methods), initiative to address the topic in the classroom, and their students’ level of interest in the topic. While recognizing the ethical considerations related to animal experimentation, the current generation of teachers and students are also eager to understand the relevance, reliability, and reproducibility of in vitro methods as the modern wave of technologies...
Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)
August 28, 2017Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10) E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with...
Collaborative Effort Aims to Replace Rabbit Test for Personal Lubricant Products
August 23, 2017Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices. The work of the lubricant industry, the Institute for In Vitro Sciences (IIVS), the PETA International Science Consortium Ltd., and...
Observation Spots Available for 2018 Practical Methods Workshop
August 23, 2017It's not too late to register for the 2018 Practical Methods in In Vitro Toxicology Workshop, Jan,16-19, at IIVS in Gaithersburg, MD. Observation spots are available for the intensive four-day workshop. Gain the scientific information and expertise you need to strategically integrate non-animal methods within your testing program. Register now....
Collaborative Effort Aims to Replace Rabbit Test for Personal Lubricant Products
August 21, 2017Study in Response to Consumer Demands for Humane Testing Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices. The work of the lubricant industry, the Institute for In Vitro Sciences...
In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
August 17, 2017In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities...