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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...
IIVS Presented with Commendation from State and Local Officials
July 24, 2017Maryland State Senator Cheryl Kagan and City of Gaithersburg Councilwoman Yvette Monroe visited our new respiratory exposure laboratory earlier this month. IIVS CEO, Rodger Curren, and COO, Hans Raabe, walked through the capabilities of the new lab with Sen. Kagan and Councilwoman Monroe, and provided information about non-animal testing. IIVS was presented with a commendation in recognition of the opening of the new laboratory. ...
IIVS at the World Congress Alternatives and Animal Use in the Life Sciences
July 19, 2017We are looking forward to attending the upcoming Tenth World Congress: Alternatives and Animal Use in the Life Sciences, August 20-24, 2017 in Seattle, WA. We have several presentations and posters at the meeting, listed below. If you will be attending, please stop by our booth - #202 - and talk with our officers and staff. We look forward to seeing you! Presentations Tuesday, August 22, 2017 10:00 am - Noon Session IX-4: Global Regulatory Updates Collaborative industry and regulatory efforts to implement alternative methods...
Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology
July 19, 2017Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in...
Webinar: Skin Tone Modulation: In Vitro Pre-clinical and Clinical Efficacy Testing Strategies and Innovative Solutions in Cosmetics
July 13, 2017Addressing uneven skin tone often associated with photo-aging is a key area of interest in the cosmetic industry. The design of novel, safe, and efficacious actives and ingredients capable of inducing subtle changes in skin tone can be accomplished using modern, relevant and reliable pre-clinical testing strategies prior to clinical assessment. During this one-hour webinar, IIVS Study Director, Dr. Gertrude-Emilia Costin and Dr. Manpreet Randhawa, Principal Scientist at Johnson & Johnson, discuss optimized in vitro testing platforms using pigmented tissue models...