Clarifying the Regulatory Road for Combination Products

Combination Products

Streamline Combination Product Development

The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products pose numerous regulatory hurdles for sponsors, even when comprised of previously cleared components — devices, delivery systems, compounds or biologics.

This paper explores medical combination product strategies to improve the regulatory journey from classification to market clearance for sponsors.

Submit this form for download.