Articles
Navigating the Regulatory Landscape of Combination Products, April 2014
Five Steps to Regulatory Strategy Development, January 2014
Navigating the New GMP Rules for Combination Products in the US, June 2013
Challenges in Combination Product Regulation, July 2012
Five Questions About Combination Products, February 2012
Combination Products Chapter in Fundamentals of US Regulatory Affairs, 2011
Developing an Effective Regulatory Strategy, December 2010
A Little Guidance for Improving Reviews of Combination Products, December 2008
Combination Products: Challenges and Progress, August 2005
FDA's Office of Combination Products -- Roles, Progress & Challenges, June 2005
Forging New Regulatory Pathways at FDA, September 2004
Mark Kramer is Named One of 100 Notable People in Device Industry, June 2004