And you can't blame them we expected some trepidation. In addition, the change in procedures creates wariness among companies because they do not yet understand how the backend reviews will work. Under the old system, the time a department examiner spent reviewing and okaying a product gave assurance that the filing met state requirements. By taking on that burden themselves, companies are taking a risk. In the meantime, said Petroluongo, the department is reviewing its staff assignments and will shift examiners to backend reviews as needed.
Most companies still rely on the traditional process.
Still, both industry and regulators believe they have seen the future of new product approvals and believe they can make it work.