Lee Ouyang, Associate, Regulatory Affairs, joined MCRA in 2010, after graduating from the Johns Hopkins University, where he studied biomedical engineering with a concentration in cell and tissue engineering. He specializes in the development of regulatory strategy and submissions for medical devices and biologics. Prior to joining MCRA, Lee worked in a laboratory specializing in tissue repair and interned at a major international pharmaceutical company.
Last December, the 2nd US Circuit Court of Appeals ruled that blocking drug companies from promoting truthful statements about off-label drug uses violates the First Amendment. The FDA decided to not pursue an appeal of this decision at this juncture, meaning that in New York, Connecticut, and Vermont, med-tech companies may give physicians information thatContinue Reading
Written on February 26, 2013 at 8:00 am
Categories: Regulatory
Tags: FDA, medical device industry
The FDA is charged with ensuring that the new medical devices it allows onto the market in the United States are safe and effective, and can reach the public in a timely way. By statute, safety and effectiveness must be based on valid scientific evidence. However, the FDA is not necessarily responsible for ensuring thatContinue Reading
Written on July 6, 2012 at 1:46 pm
Categories: Regulatory
Tags: FDA
The medical device industry’s product design and regulatory infrastructures set up a difficult competitive landscape for most start-ups. Most mid- and large-cap medical device manufacturers’ infrastructures create virtual walls that segregate the “design guys” from the “regulatory guys,” getting in the way of ultimate product development. The Problem Prototype devices will often have novel featuresContinue Reading
Written on September 26, 2011 at 10:42 am
Categories: Regulatory
Tags: FDA, medical devices, product design, regulations
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