FDA and Bioinfogate Agree to Extend for Two Additional Years the Material Transfer Agreement to Provide Agency-Wide Access to the OFF-X Translational Safety Intelligence Portal

The agreement aims to evaluate new approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets, supporting the FDA’s mission of protecting public health.

Under this MTA, the FDA has agency-wide access to Bioinfogate’s translational safety intelligence portal, OFF-X. The primary objective of the agreement is to evaluate the use of Bioinfogate OFFX™ as a research tool to anticipate adverse events associated with molecular targets, as well as with new and marketed drugs. The MTA also aims to evaluate OFF-X’s utility in the regulatory review process. As the collaboration enters its fourth year, the FDA will continue to provide feedback on the utility of the OFF-X database and/or any aspects related to new functionalities.

Unexpected safety issues constitute one of the most disruptive events in clinical research. A translational approach to drug safety that integrates preclinical and clinical data can significantly reduce patient burden and avoid costly failures. In this context, it is essential to detect as early as possible in the drug R&D process the potential safety liabilities associated with new targets, drugs under development and recently marketed compounds.


FDA/CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. FDA/CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients.

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