FDA Launches Global Rx Quality Initiative With Plans To Rely On Non-U.S. Regulators
This article was originally published in PharmAsia News
Agency restructures staff as it prepares for new U.S.-EU mutual reliance activities to enhance pharmaceutical quality but 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.
Agency’s Program Alignment Group recommends “commodity-based and vertically-integrated programs” to improve efficiency and communication.
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.