NCHR Testimony at the FDA on an Oral Drug for Ulcerative Colitis

March 8, 2018. We are concerned that the clinical trial data do not adequately represent the real-world population of patients who will be likely to consider this drug. We strongly recommend more persuasive data including a more diverse group of patients before making a decision about supplemental approval of the two proposed dosing regimens for induction non-responders and those with prior TNF blocker failure.

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

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.

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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.

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