November 1, 2010. A major concern is that the medical device user fees are too low to adequately support the Center for Devices and Radiological Health’s (CDRH) efforts to clear or approve safe and effective medical devices in a timely manner.
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NCHR Testimony at FDA Public Meeting on the Reauthorization of the Medical Device User Fee Act (MDUFA)
September 14, 2010. If a device can kill you if it fails, or if it doesn’t work accurately, then it should be considered a high-risk device, not just a high-risk recall.
Read More »NCHR Testimony at the Chronic Hazard Advisory Panel (CHAP) on Phthalates
July 26, 2010. Phthalates have been shown to cause adverse health effects. Due to the fact that safe alternatives to phthalates are available now, we urge industry to switch to these alternatives.
Read More »Patient, Consumer, and Public Health Coalition Comments to FDA on Direct-to-Consumer Prescription Drug Advertisements
June 28, 2010. These proposed changes are steps in the right direction, but we continue to have strong reservations about direct-to-consumer prescription drug ads, and we will continue to urge Congress to restrict or ban them.
Read More »Comments to the FDA on Bottled Water and the Proposed Allowable Level for the Chemical Di(2-ethylhexyl)phthalate (DEHP)
May 27, 2010. Scientific evidence suggests that phthalates may be harmful to humans, and increase the risk of serious diseases such as cancer and reproductive problems.
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