In 2016, the Food and Drug Administration (FDA) released its final rule for postmarketing safety reporting requirements for combination treatments that involve a drug, device, and/or biological product. Pharmaceutical and medical device manufacturers nationwide are required to comply with the new regulations by July 31, 2019, or face potential penalties.
Building off a longstanding relationship, a major pharmaceutical manufacturer partnered with Guidehouse to guide them in their preparation for the new legislation. The company is leveraging Guidehouse’s experience advising medtech and pharmaceutical companies with combination products to better understand and implement industry best practices.
Guidehouse has helped the pharmaceutical manufacturer map its existing adverse event reporting processes and identify gaps that arise due to the new reporting requirements. In addition, the organizations are working to amend existing processes to ensure that the combination product reporting requirements are fully met. This includes training staff on the new processes and creating scenarios to pilot through the processes to ensure adequate performance.
Guidehouse has also advised the client on topics associated with the new reporting requirements, including how to:
Although an adequate adverse event reporting system requires constant oversight and refinement, it is anticipated that the pharmaceutical manufacturer will be ready to comply with the FDA’s new adverse event reporting requirements by the effective date.
As the FDA’s reporting requirements are just one piece of a global puzzle, the pharmaceutical manufacturer is also expected to take advantage of Guidehouse’s European regulatory presence to meet new European Union Medical Device Regulation requirements.