Washington, D.C., September 17, 2009 — On Wednesday, September 16, James S. Cohen — a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office — served as a session leader and presenter at the Regulatory Affairs Professional Society (RAPS) Annual Conference in Philadelphia. Cohen presented "FDA's New Approach to Good Manufacturing Practice (cGMP) Requirements for Combination Products: The What's Why's and How's," which 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.

The event was attended by the largest, concentrated group of regulatory professionals — nearly 2,000 delegates. Leading industry representatives, including FDA officials, business experts and global regulatory authorities from Health Canada, MHLW, PMDA, DCGI and the Dutch Healthcare Inspectorate, attended the four-day conference.

Cohen is a nationally recognized attorney in the area of compliance with cGMP and other requirements for combination and other FDA regulated products and in addressing and responding to the government's post-market regulation of FDA products. Prior to joining Buchanan, Cohen spent more than 17 years in senior legal, program and policy positions with the U.S. Food and Drug Administration (FDA). During his tenure at the FDA, he led the agency's development of the Proposed Rule on Current Good Manufacturing Practice for Combination Products, which will be published by the FDA within the next several weeks.

About RAPS


The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the health care product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel.