Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers

A new, free white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download from the Article Webpage.

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO, and USP.

Steven Richter, Ph.D., Microtest President & Chief Scientific Officer, addresses the critical issues associated with this complex process, including defining the FDA’s regulatory framework, reviewing developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.

"The combination products market – medical devices embedded with pharmaceutical or biologics components – is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements," said Richter, who is author of the announced white paper, "Combination Products: Navigating Two FDA Quality Systems."

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

"For manufacturers, the convergence of devices and drugs or biologics also brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products," he said.

The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations. It can be downloaded now from the Article Webpage.