FDA data "insufficient for review cost assessment"
This article was originally published in Clinica
The FDA's report on how much it costs the agency to conduct a product review will not provide the level of detail industry initially wanted. Dr Dale Geiger, the independent contractor conducting the study, told industry last week that the agency's labour reporting system is a truly "blunt tool". It does not differentiate between various types of premarket approval (PMA) applications, whether they be original, product development protocols, modular, expedited or panel-track supplements of Human Device Exemptions.