PDUFA VII will help clarify CMC requirements for cell and gene therapy firms according to the Alliance for Regenerative Medicine (ARM), which says regulations around such products are moving in the right direction. The Prescription Drug User Fee Act (PDUFA) VII – legislation that enables the US FDA to collect use fees from drug developers and strengthens the agency’s review capabilities for small and large molecule drugs and advanced therapeutics – covers the fiscal years 2023 to 2027. Cell and gene…