FDA Plans To Rely On Non-U.S. Regulators In Global Drug Quality Initiative
This article was originally published in The Tan Sheet
FDA restructures its staff as it prepares for new U.S.-EU mutual reliance activities to enhance pharmaceutical quality, but it offers few details on upcoming plans.
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New deputy commissioner Howard Sklamberg tells “The Pink Sheet” that globalization of the drug supply eventually will become more commonplace, and ideally less of a concern, for American consumers.
Howard Sklamberg, currently director of the CDER Office of Compliance, will take over the Office of Global Regulatory Operations and Policy after a year as CDER compliance office director.
In contrast to the existing inspection program for clinical trials, sites around the globe will be targeted.