On September 16, 2009, James S. Cohen presented "FDA's New Approach to Good Manufacturing Practice (cGMP) Requirements for Combination Products: The What's Why's and How's" at the Regulatory Affairs Professional Society (RAPS) Annual Conference in Philadelphia. The presentation provided an overview of FDA's proposed rule on cGMPs for combination products; the legal basis and rationale; the application of the quality system regulation (devices) and the cGMP regulations (drugs); the implications for device and drug companies; and suggestions on how to meet new requirements.