What Factors In The Development Process Could Affect Risk Identification?
Table of Contents: Managing the Risks from Medical Product Use: Creating a Risk Management Framework Previous Section : How well is the Agency’s Quality Control System working? The clinical community and FDA have long recognized that, even given the flawless functioning of both the manufacturer’s product development process and the FDA’s review process, factors inherent in the current medical product development system will continue to limit FDA’s ability to identify all potential risks in new medical products. In interviews with the directors of the Center for Drugs, Center for Biologics, and Center for Devices and with the premarketing biostatistics office directors about their experience with premarketing reviews and about the product development process and its limitations, we identified the following factors that could be affecting the Agency’s ability to identify potential risks prior to medical product marketing. Trials expose only a relatively small number of people to a produc
