Regulatory Actions
New Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
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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