FDA Launches Global Rx Quality Initiative With Plans To Rely On Non-U.S. Regulators
This article was originally published in PharmAsia News
Executive Summary
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.
You may also be interested in...
How FDA Plans To Stop Worrying And Love Globalization
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.
FDA Reorganization To Focus On Employee Specialization
Agency’s Program Alignment Group recommends “commodity-based and vertically-integrated programs” to improve efficiency and communication.
FDA Again Taps Compliance Director For Globalization Post
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.