The commitment to a more collaborative and transparent quality approach allows the FDA to modify internal processes for program participants. View the regulatory modifications here.
Compared to an inspection, one program participant reported a savings of 1000+ personnel hours, 90% of the dedicated resources, and tens of thousands of dollars.
Streamlined submissions are reviewed and approved an average of 75%-90% faster, leading to an increase in the number of changes to improve product quality, availability, and cost.
The ability to make more improvements faster has led to accelerated time to market and the re-deployment of FTE resources.