Commonwealth Informatics has signed a new contract to support the use of advanced drugs safety tools at the FDA Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
Commonwealth Informatics has signed a new contract to support the use of advanced drugs safety tools at the FDA Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This contract was a follow-up to an FDA Agreement announced in June, which includes:
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A one year commitment of ~$900K for support and consulting and four additional option years with an increasing amount each year.
Support for one of the largest implementations of Oracle Empirica Signal as with up to 300 users accessing the suite to track the safety of marketed drugs and those in the approval process - recent batch of new drug approvals requires more safety review.
The contract provides support for the FDA’s 21st Century regulatory review process initiative.
