April 11, 2022. In light of the ongoing opioid epidemic, we commend FDA’s goal of fostering the development of non-addictive alternatives to opioids for managing acute pain, and thereby decreasing exposure to opioids and preventing new addiction.
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Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee
February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
Read More »NCHR Statement about Hydexor at FDA Opioid Advisory Committee Meeting
There is clear evidence that opioid REMS have not worked in the past, and it is not possible to enforce them. NCHR encourages the committee to encourage the FDA to not approve an opioid that has not even been studied for efficacy compared to non-opioid pain meds, given the unproven ability to enforce REMS compliance.
Read More »NCHR’s Comments on FDA’s Information Collection Activities on Abuse Deterrent Formulations
April 6, 2020: We support FDA’s decision to conduct a comprehensive evaluation of opioid prescribers’ knowledge, attitudes, perceptions, experiences and behaviors related to Abuse Deterrent Formulations (ADF) and agree with the FDA that new language is needed to better describe and explain ADF.
Read More »NCHR Testimony on Aximris as an Abuse-Deterrent Opioid for Long-Term Treatment
January 15, 2020. FDA should require sufficient evidence that this drug’s abuse-deterrent properties will result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes.
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