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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





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