News | December 04, 2007

Free White Paper Discusses Challenges of New FDA Rules for Combo Product Makers

December 4, 2007 - A new, free white paper, addressing the challenges of new FDA regulations awaiting combination products manufacturers, is now available for download from Microtest, a testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries.

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.

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 percent of new products under development today are combo products.

The paper’s contents include defining the convergence, FDA responsibility, QC drug release criteria, biologics, new developments in FDA thinking and future considerations.

For more information: www.microtestlabs.com/combinationpaper

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