House Globalization Bill Would Require FDA to Inspect All Plants

Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) introduced a globalization bill mandating that the FDA inspect drug and device plants in the U.S. and abroad every two years, unless the agency decides a facility’s record requires fewer reviews. The FDA Globalization Act would fund increased good manufacturing practice inspections for brand and generic drugs by requiring companies to register drug and device plants annually, including foreign companies that export drugs or devices to the U.S., and pay fees for the registrations.
Drug Industry Daily