The Food and Drug Administration published a final rule governing Current Good Manufacturing Practice (CGMP) requirements for combination products, that is products that combine devices, drugs and/or biologics, usually regulated by separate FDA divisions. This rule is intended to provide clarification on CGMP requirements for combination products.
In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.
The new guidelines apply to existing products, as well as new ones. The rule is effective July 22, 2013.
