Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

In 2013, the Food and Drug Administration (FDA) published the final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule is intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create 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.

In Part One of this session, industry and FDA speakers will present updates on the recently published draft CGMP guidance associated with the final rule and the ongoing dialogue between industry and FDA regarding implementation of the rule. In Part Two of this session, a panel of FDA representatives from CBER, CDER, CDRH, ORA, and OCP – all experts in combination product regulation – will share their learnings and answer questions from the audience on this important topic.