NCHR Comments to FDA on Nicotine Replacement Therapy (NRT) Product Uses and Labeling Changes

FDA, February 15, 2018. It remains unclear whether individual achievement of abstinence is sustainable over time and whether long-term NRT use is more or less beneficial on an individual or population health level. We commend the FDA for addressing their role in developing strategies to evaluate NRT products and labeling. We agree that urgent action is necessary and the FDA should consider science-based approaches to reduce further harm from combustible tobacco products.

Read More »

NCHR Comments on Changes to Medical Software Policies Due to 21st Century Cures Act

February 15, 2018. The draft guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act removes FDA evaluation of EHRs and leaves only certification by the Office of the National Coordinator for Health Information Technology (ONC) to ensure that software is both functional for providers and safe for patients. However, ONC certification is not sufficient to protect patients from problems with EHR software.   For that reason, the draft guidance as written puts patients’ lives at risk.

Read More »

NCHR Testimony at FDA About New Opioid Combination, Hydexor

February 14, 2018. Consider how this drug fits into the context of the drug market and how it is likely to be used or misused. Do the benefits outweigh the risks of putting another conventional opioid on the market, one that is designed to treat its own side effects, and are the attempts to reduce excess pills sufficient? Opioids provide both a benefit and a harm in our society. As Advisory Board members, please advise the FDA to carefully and cautiously consider the potential for abuse of this opioid.

Read More »
Page 1 of 9212345...102030...Last »