Published in Medical Letter on the CDC and FDA, June 3rd, 2007
"The combination products market - medical devices embedded with pharmaceutical or biologics components - is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements," said Steven Richter, Ph.D., Microtest President & Chief Scientific Officer. Richter, a former FDA official, is author of the announced new white paper, "Combination Products: Navigating Two FDA Quality Systems."
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