White Papers for Food and Drug Administration (FDA)

Combination Products: Navigating Two FDA Quality Systems

Microtest

While combination products are experiencing dramatic growth, the convergence of drugs/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. Dr. Steven Richter of Microtest Labs addresses the critical issues associated with this complex process, including defining the FDA’s regulatory framework, reviewing new developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.

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