White Papers for Food and Drug Administration (FDA)

Navigating Two FDA Quality Systems

Microtest

The combination products market is moving forward with a new direction and emphasis regarding product
safety and FDA requirements. Navigant consulting estimated the market at $5.9 billion in 2004 and predicted
a 10% compound annual growth rate that will see the market reach approximately $9.5 billion in 2009. The
FDA received 275 combination product submissions in 2005. According to one survey, an estimated 30% of new products under development are “combo products” - involving medical devices embedded with pharmaceutical or biologics components. On the forefront, a new crop of experimental heart stents have been filed with the FDA. The Abbott Labs “absorb” product represents a significant change to existing drug eluting stent technology. Along with new breakthrough technologies like absorb, FDA regulatory centers are struggling with the changes and challenges that these new technologies posit. But for manufacturers, along with these exciting new opportunities, the convergence of drugs/biologics and devices also brings a host of regulatory challenges. One – underway now in the regulatory departments of both pharmaceutical and medical device manufacturers – focuses on their struggle to address a host of testing guidelines, practices, and regulations unique to the development and production of combination products.

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