Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|December 16, 2016
Commonwealth Signs Agreement with FDA
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.
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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
- 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.
Read the full release
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