FDA Update

FDA Revises Final Guidance

Combination Products Update

The U.S. Food and Drug Administration published the revised final guidance Application User Fees for Combination Products. This guidance replaces the final guidance of the same title issued in 2005, and includes revisions for consistency with the current user fee programs and revisions to reflect combination product provisions in the FD&C Act (section 503(g)).

Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. This guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also explains how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts.

This guidance should be used in conjunction with the guidance for industry Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products and the appropriate medical device user fee amendments (MDUFA) guidance document(s).

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