12. August 2018

The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. In concert withthe method revamp, the agency introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections. Great article by Jerry Chapman At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio,...