FDA’s proposed Expanded Access Navigator points to progress, not panacea

In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort to increase the efficiency of the complex process of requesting unapproved drugs outside of clinical trials for “compassionate use.”

Vince & Associates’ new research center reflects recent QT regulatory changes

A new early-phase research center opened this month in Kansas by Vince & Associates Clinical Research includes a specialized QT safety assessment unit, which reflects recent regulatory changes to cardiac safety assessments that could bring more drugs to the pipeline and cost savings to sponsors.

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