FDA and Clarivate Extend Material Transfer Agreement

  Clarivate Plc (NYSE: CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the extension of the Material Transfer Agreement (MTA) with the FDA for an additional three years. The extension will ensure continued agency-wide access to OFF-X™ by Clarivate, which provides integrated preclinical toxicity, clinical and post-marketing adverse event data, visualizations and analytics.

The success of clinical research can be jeopardized by unexpected safety issues. It is critical to identify potential safety liabilities as early as possible in the drug research and development (R&D) process. A translational approach to drug safety data can reduce patient burden and support increased success by harmonizing preclinical and clinical data.

As the collaboration enters its sixth year, the FDA will continue using OFF-X as a solution to identify potential adverse events associated with molecular targets and new and marketed drugs and its utility in the regulatory review process. The agreement enables the continued support of the FDA's mission of protecting public health by evaluating approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets.

https://finance.yahoo.com/news/food-drug-administration-fda-clarivate-070000627.html