Informed Consent regulations must be updated to give trial participants more information on potential life-and-death safety concerns, contends Center for Responsible Science
Unreliable drug testing practices put the lives of clinical trial participants at risk, contends Center for Responsible Science
Los Angeles, Calif., May 17, 2017 — With at least 20 treatment-related deaths in clinical drug trials between May 2016 and April 2017, Center for Responsible Science (CRS) has updated its July 2015 citizen petition, also adding a declaration from the father of a 24-year-old patient who died two days after receiving an experimental cancer therapy developed by Juno Therapeutics.
After CRS research goes public, FDA clarifies stance on Draize Rabbit Test but does not go far enough
Los Angeles, Calif., May 26, 2016 -- A coalition led by Center for Responsible Science (CRS) has submitted a citizen petition urging the Food and Drug Administration (FDA) to issue broad guidance communicating clearly with drug and device sponsors that the Draize rabbit test for skin and eye irritation is no longer required and that human relevant in vitro tests will be accepted. To assist FDA with this request, CRS has submitted a proposed draft guidance.
Unreliable drug testing practices put clinical trial participants and consumers at risk, contends Center for Responsible Science
Los Angeles, Calif., March 29, 2016 — With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the Food and Drug Administration (FDA) to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.
Advancing Regulatory Science includes allowing for the most predictive test
Washington, D.C., July 31, 2015—A coalition of non-profit advocacy organizations, technology developers and patient interest groups are calling for the Food and Drug Administration (FDA) to update regulations that govern preclinical drug and device development.