USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed

The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.

A USP official discussed both reports, as well as his perspectives on the industry’s adoption of advanced manufacturing methods, in an interview with Focus