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.