Addressing FDA Approval Challenges Facing Combination Product Manufacturers
Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics componentsis expected to become even more challenging and complex.
"Given the convergence of technologies, combination product manufacturers - often either medical device or pharmaceutical companies 'crossing over to the new market' - must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP)," said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.
"The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements," said Richter. "The process, already complex, is likely to become even more so," he warned.
In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions "raise challenging regulatory, policy, and review management issues... [that] can impact the regulatory processes of all aspects of the product life cycle."
In the free white paper, "Combination Products: Navigating Two FDA Quality Systems," Richter provides a helpful overview of the challenges facing combination product manufacturers.
"For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products - and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer," he said.
In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.
According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.