March 24, 2015. We strongly agree with the Dietary Guidelines Advisory Committee’s report of a healthy diet as one that is: higher in fruits, vegetables, whole grains, low-fat dairy, seafood, legumes, and nuts; lower in red and processed meats; low in sugar-sweetened foods and drinks; and lower in sodium.
Read More »On Health Policy
Comments on Transfer of Premarket Notification Clearance
March 23, 2015. We support the draft guidance with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device.
Read More »Analysis of Impact of Device Excise Tax on U.S.-Based Medical Device Companies
April 16, 2015. The purpose of the 2.3% excise tax on medical devices, which was implemented in January 2013, is to raise revenue to help support health insurance coverage for the millions of Americans who have been unable to afford it.
Read More »Testimony from Members of the Patient, Consumer, and Public Health Coalition on 21st Century Cures Discussion Draft
February 27, 2015. This is a very brief summary of the concerns of coalition members. The purpose of federal regulations is to protect the U.S. public from harm by implementing reasonable safeguards.
Read More »Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act
February 12, 2015. The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics. HEAL is the first bill to focus on both these necessary actions.
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